Family-based prevention of overweight and obesity in children aged 2–6 years: a systematic review and narrative analysis of randomized controlled trials

Figures & data

Figure 1. Exam 1 Spreadsheet

Table 1. Characteristics of included studies

Author/year/Intervention name/country	Study Design	Participant characteristics	Intervention components	Outcome measures and follow-up
Barkin et al. 2012 USA	Randomized controlled trial Period: October 2008 and February 2009	• Children aged 2–6 • Underweight (BMI < 5^th percentile) • Normal weight (BMI ≥ 5^th to <85^th percentile) • Overweight (BMI ≥ 85^th to < 95^th percentile) • Obese (BMI ≥ 95^th percentile)	Focus of intervention: Behavioural intervention on BMI Intervention group component • Weekly 90 minute skills-building sessions for parents and preschool-aged children designed to improve nutritional family habits, increase weekly physical activity, and decrease media use (sedentary activity) • The intervention involved a series of 12 group sessions occurring between March and June 2009 • Participants were also assigned to small social groups where they were assigned small activities and specific group roles Control group component • Brief school readiness programme • Participants met 3 times for 60 minutes over the 12-week study period. The control group programme was designed to improve school readiness in preschool-aged children through increased parental verbal engagement (e.g. daily reading, playing word games, how to talk to children.	• Height and weight • BMI at 3-month follow-up • Acculturation measured by Short Acculturation Scale for Hispanics (follow-up time point unclear)
Berry et al. 2011 USA	Randomized controlled trial Period: March 2009 and February 2010	• Male and female children aged 2–4 • Children at any BMI percentile	Focus of intervention: weight management Intervention group components • A community health educator taught the nutrition and exercise education and coping skills training classes once a week for 12 weeks • The nutrition education classes focused on learning about healthy, low-cost food choices, portion control, and lowering fats and calories for mothers and also provided tips on how to make these changes with their children • The exercise education classes focused on increasing exercise for both mothers and their children • The coping skills classes used social problem solving, conflict resolution, and cognitive restructuring to help the women make healthy nutrition and exercise choices • Mothers attended exercise programmes while their children’s exercise classes included Colour Me Healthy which is a programme that focuses on healthy nutrition choices and increased activity and using examples of new and colourful foods, games, songs, and dancing for children 3–5 years of age Control group components • Waitlist control group	• Weight outcomes, BMI percentiles for children, at baseline and 9 months
Haines et al. 2013 Healthy Habits, Happy Homes, USA	Randomized controlled trial Period: June 2011 to February 2012	• Male and female children aged 2–5 years • Normal weight children (BMI < 85^th percentile) • Overweight children (BMI 85^th – <95^th percentile) • Obese children (BMI > 95^th percentile)	Focus of intervention: Promoting four household behaviours: Eating meals together as a family, obtaining adequate sleep, limiting TV time, and removing the TV from the child’s bedroom Intervention group components • Home-based intervention • Motivational coaching by health educator during 4 home visits and 4 health coaching telephone calls, to encourage behaviour change related to excess weight gain • Mailed educational materials and incentives • Weekly text messages (twice for 16 weeks and then weekly for the last 8 weeks of the programme) on adoption of household routines Each home visit included: A check-in to review progress and setbacks to behaviour change, a discussion of behaviour change goals and collaborative goal setting, and a concrete activity or tool the parent could use to support behaviour change Control group components: • Families received 4 monthly mailed packages that included educational materials on reaching developmental milestones during early childhood	Primary outcomes: • eating meals together as a family, • Child’s sleep duration • Child’s TV viewing time, and • presence of a TV in the room where the child slept Secondary outcomes: • Change in child BMI All primary and secondary outcomes measured at baseline and 6-month follow-up
Hart et al. 2016 Confident Body, Confident Child (CBCC) Australia	Randomized controlled trial	• Children aged 2-6 years • No exclusion due to weight status	Focus of intervention: to promote body satisfaction, healthy eating, and weight management in early childhood Intervention group components Two intervention groups: (A) received the CBCC resource pack and a 2 h workshop. (B) received the CBCC resource pack only Control group components Two control groups: (C) received a nutrition-only resource (Happy healthy kid). (D) waitlist control	Outcomes • Knowledge Test for Body image and Eating patterns in Childhood (BEC) • the two subscales (positive and negative behavioral intentions) of the Parenting Intentions for (BEC) • four measures of family meal times • six parental feeding practice scales • BMI for the parent and BMI-z for the child • Outcomes were measured at baseline and after 6 weeks
Martínez-Andrade et al. 2014 The Creciendo Sanos Mexico	Pilot, cluster-randomized trial	• Male and female children between the ages 2 to 5 years WHO BMI z-score category: • Normal ≤1.0 • Risk of overweight (>1.0 – ≤2.0) O• verweight >2.0	Focus of intervention: Nutrition and physical activity Intervention group components • Participants received a 6-week curriculum focused on obesity awareness and prevention • A nutritionist led diet, healthy growth and physical activity workshops while a health educator led workshops on instilling healthy habits and routines in childhood • A nurse provided childcare and developed relevant games and activities for children while parents attended workshops • The 6 educational sessions were 2 hours each Control group components Usual standard of care	• Child intake (sweet snacks, fast food, savoury snacks, sugar-sweetened beverages, fruit, vegetables, water, added sugar in beverages) baseline and at 3 and 6 month follow-up • Physical activity at baseline and 3 and 6 month follow-up • Total hours/week of screen baseline and 3 and 6 months • Children’s BMI baseline, 3 months and 6 months follow-up
Slusser et al. 2012 USA	Randomized controlled pilot study	• Children 2–4 years old Children classified as: • Healthy weight • Overweight, and • Obese	Focus of intervention: Promote physical activity and healthy eating Intervention group components • Seven weekly modules followed by two monthly modules of parent training based on social learning. Class sessions were designed to incorporate healthy nutrition and physical activity • Increase caregiver’s knowledge about yes and no foods • Teach families how to practice behaviour modification strategies • Teach parents food strategies to increase vegetable and fruit food preferences • Identify barriers to healthy lifestyles and review strategies to review these barriers • Classes lasted 90 minutes • Demonstrations by social worker and roleplaying by the mothers • Mothers received one-page handout with information covered in class Control group components • Mothers received care as usual and received a standard nutritional informational pamphlet • Received intervention after one year follow-up	• BMI percentiles and • BMI z-scores Outcomes measured at baseline, 4 months, and 12 months
Smith et al. 2015 USA	Multisite randomized controlled intervention trial	Children 2 years 0 months and 2 • years 11 months Children’s BMI was not available at baseline so body size was rated on a 1–9 scale i.e. • 1=not at all overweight • 5=somewhat overweight 9=overweight	Focus of intervention: Parenting and meal-time behaviours Intervention group components • Intervention participants received the Family Check-UP (FCU) • FCU is a brief, three-session intervention that is tailored to the individual needs of each family. The three meetings include an initial contact session, a home-based multi-informant ecological assessment, and a feedback session • FCU uses an ecological framework to intervene with families to improve children’s adjustment by motivating positive behaviour support (PBS) • PBS involves the caregiver being proactive and structuring the home in ways that promote healthy development Control group components • Received the Women, Infants, and Children Nutrition Programme (WIC) as usual.	• BMI and body size BMI • Nutritional quality • Chaotic home environment using the Confusion, Hubbub and Order Scale • Child non-compliance • Inhibitory control assessed with the 13-item Inhibitory Control subscale of the Children’s Behaviour Questionnaire BMI assessed yearly from age 5 to 9.5 years Follow-up measures of other outcomes not clearly stated
Tomayko et al. 2016 The Healthy Children, Strong Families-study USA	Quasi-RCT (parents who could not attend the meetings were transferred to the control group Period: ?	• Children aged 2-5 years • No exclusion due to weight status	Focus of intervention: Nutritional and behavioural changes Intervention group components • Twelve culturally appropriate lessons were designed by researchers together with tribal mentors, addressing the target ideas 1. To eat more fruit and vegetables, 2. Consume less sugar, 3. Become more active and 4. Watch less TV. • A trained home mentor did 12 monthly home visits. Control group components • Families in the control group got the same lessons delivered by mail monthly.	Primary outcomes • BMI for the parent and BMI-z for the child Secondary outcomes • Three 24 h dietary recall diaries (child intake: fruits and vegetables, sugar-sweetened drinks, candy, junk food) • screen-viewing time • Physical activity was measured using Actical accelerometers Self-perception of efficacy for health-related behaviours Outcomes were measured at baseline, after 1 and 2 years
Walton et al. 2016 Canada	Pilot RCT	• Male and female children in the age ranges 2 to 5 years • Children eligible regardless of weight status	Focus of intervention: Parental roles in promoting healthy nutrition and activity behaviour among their children Intervention group components • Intervention ran for 9 weekly 2-hour group sessions • Approximately 65% of programme content focused on general parenting and 35% on weight-related behaviours • The intervention used video vignettes, facilitated group discussions and homework • Group facilitator received training in group facilitation skills (4 hours) Control group components • Intervention ran for 9 weekly 2-hour group sessions • The programme content focused on child injury prevention • The intervention used video vignettes, facilitated group discussions and homework Group facilitator received training in group facilitation skills (4 hours)	Primary outcomes • Feasibility and acceptability Secondary outcomes • BMI z scores • Parental warmth • Follow-through on discipline • Parenting stress • Parent use of food as reward • Parental self-efficacy in managing child behaviour and child intake • Child sleep • Child physical activity – active play • Child sugar-sweetened beverage intake • Child TV viewing • Nutrition risk score Primary outcomes assessed by study protocol and post intervention survey. Secondary outcomes assessed at baseline, post-intervention and at 9-month follow-up
van Grieken et al. 2013 Be Active Eat Right study The Netherlands	Cluster randomized controlled trial Period: September 2007 -October 2008	• 5-year-old children • Normal weight children, • Overweight children, and • The Obese children	Focus of intervention: Behavioural change Intervention group components • Parents received a prevention protocol which offered them information regarding overweight prevention and healthy choices by using a motivational interviewing approach, if needed to motivate the parents to change behaviour • The prevention protocol was initiated during the well-child visit and in addition up to three structured healthy lifestyle counselling sessions to promote overweight-prevention behaviours could be offered approximately 3, 6, and 12 months after the well-child visit • The four lifestyle-related behaviours described in the protocol and could be promoted include: playing outdoors and eating breakfast, and reducing sweet drinks and sedentary behaviour Control group components • Parents were informed about the overweight of their child but usual care was given. Usual care consisted of general information about healthy lifestyle during the well-child visit.	Primary outcomes • BMI • Waist circumference 2-year follow-up
Yilmaz et al. 2015 Turkey	Randomized controlled trial Period: September 2010 - October 2012	• Male and female children 2–6 year olds • Children’s weight status not specified	Focus of intervention: Reducing screen time Intervention group components Intervention had 4 main components: three printed materials and one interactive CDs, and one counselling call 1. First set of printed materials given after baseline followed by a counselling phone call two weeks later. The second printed materials were distributed at the 4^th and 6^th week. Printed materials and CD were aimed to decrease screen time at home and parents read age-appropriate books to their children daily, family meal time with TV turned off, offer alternative activities to watching TV 2. Second component was a counselling call, encouraging families to make their home screen-free, benefits of screen-free home, and difficulties to establish and keep screen-free home 3.Third component included a picture book showing a family while making their home screen-free 4. Fourth component included information about stories of families that were able to decrease their screen time Control group components Control group answered questionnaires and home visits	Primary outcomes • Children’s TV/video watching and computer/video game playing at 2, 6, and 9 month follow-up BMI measured at baseline and 9 months
Østbye et al. 2012 KAN-DO study USA	Randomized controlled trial Period: November 2007–October 2009	• Male and female children in the age ranges 2 to 5 years • Underweight • Normal weight • Overweight (≥ 85^th – <95^th percentile) • Obese ≥95^th percentile	Focus of intervention: Diet, physical activity and sedentary behaviour Intervention group components • Participants received 8 monthly mailed interactive kits, followed by a 20–30-minute telephone coaching session using motivational interviewing techniques. Kits included child activities and incentives reinforcing the month’s topic • Intervention targeted the dyads healthy weight via instruction in parenting styles and skills, techniques for stress management and education about healthy behaviours. • Coaching calls reviewed information in the module and addressed motivation, self-efficacy, and barriers to change. • Intervention also included semi-structured group sessions where study coaches and nutritionist reinforced content from the family kits. Parenting skill and instruction emphasized: An authoritative parenting style, routines for sleep and meal times, a supportive home environment, role modelling of healthy eating and physical activity and improvement of feeding style Control group component: Control arm participants received monthly newsletters emphasizing pre-reading skills. Retention was encouraged by monetary incentives	Outcomes: changes in • Regular family meals, measured by the Family Meals Questionnaire • Child dietary intake of sugary beverages, fast food, fruits and vegetables • Physical activity and sedentary time measured by accelerometer • Television viewing reported by mother • Healthy food availability in the home • BMIz-score • Parenting competence in emotional regulation Outcomes measured at baseline and 12-month follow-up

Figure 2. Exam 1 Spreadsheet

Figure 3. Exam 1 Spreadsheet

Table 2. Summary of main findings on primary outcome; BMI, BMI percentiles and BMI z score

	No. of randomized participants
Author/Year/Design	Intervention	Control	Outcome	Follow-up	Results for completors
Barkin et al. 2012	54	52	Absolute BMI	Post 3 month intervention	Intervention (n=35) Mean ± SD			Control (n=40) Mean ± SD
					–0.51±0.87			0.06±
Berry et al., 2012	Unclear(altogether 56 participants)	Unclear	BMI percentiles	9 month post intervention		Baseline		9 months
						Intervention	control	Intervention	Control
					Body mass percentile	86 (+/–7.5)	86 (+/–11.1)	82 (+/–6.8)	88 (+/–8).5)
Haines et al. 2013	62	59	BMI	Post 6 month intervention	Mean (SD)
					Child BMI	Baseline	6 months	change	Difference β (95%CI)
					Intervention (n=55)	17.34 (1.12)	17.16 (1.99)	–0.18 (0.98)	–0.40 (–0.79 to 0.00)
					Control (n=56)	17.36 (2.73)	17.57 (3.22)	0.21 (1.07)
Hart et al., 2016	Group A: 97 Group B: 111	Group C: 91 Group D: 79	BMI z-score	6 weeks post intervention	BMIz after 6 weeks			Group A (n=64), group B (n=90), group C (n=75), group D (n=68) no significant differences between groups at 6-weeks; F (3,282) = 1.30, p=0.27. There was a slight decrease in the intervention groups and a slight increase in the control groups
Martínez-Andrade et al. 2014	168	138	BMI z score	3, and 6 months post intervention		Change BL-6m Mean (SE)	Unadjusted Est (95% CI)		Adjusted Est (95% CI)
					Intervention (n=109)	–0.18 (0.01)	0.06 (–0.14, 0.27)		0.03 (–0.17, 0.23)
					Control (n=102)	–0.25 (0.01)
Slusser et al., 2012	80	80	BMI and BMI z-score	4 months, and 12 months post intervention		Intervention (n=61)		Control (n=60)
						M (SE) P		M (SE) P
					BMI z-score difference from baseline to 12 months	−0.20 (0.08) .01		0.04 (0.09) .64
Smith et al. 2015	367	364	BMI	3 year post intervention	Model path	B	SE (B)	β	95% CI
					Nutritional quality →BMI LGC slope	–0.003*	0.00	–0.22	0.152 | 0.337
					*p<0.05
Tomayko et al. 2016	67	83	BMI z-score	1 and 2 years post intervention		Intervention (n=45)	Control (n=69)	statistic
						M ± SD	M ± SD
					zBMI after 1 year	+0.1±1.0	+0.1±1.0	P=0.937
					zBMI after 2 years	+0.09% ± ?	–0.15±0.95	P=0.80
Walton et al. 2016	29	25	BMI	Post intervention and 9-month follow-up		Post intervention	Adjusted difference	9 months	Adjusted difference
					BMI	Mean (SD)	P value	Mean (SD)	P value
					Intervention (n=27)	16.3 (1.56)	–0.22(–0.57,0.13) P=0.21	16.4(1.88)	–0.07 (0.07,0.58) p=0.82
					Control (n=21)	16.4 (1.36)		16.3 (1.61)
van Grieken et al. 2013	349	288	BMI	2 years follow up	BMI (n=505)
					Beta coefficient	(95% CI)	p value
					Model 3 corrected for cluster	–0.16 (–0.60; 0.27)	0.463
Yilmaz et al. 2015	211	201	BMI z-score	9-month follow-up		Intervention (n=187)	Control (n=176)	statistic
						M ± SD	M ± SD
					zBMI at baseline	–0.19±1.12	–0.22±0.81	P=0.375
					zBMI at 9 months	–0.13±1.05	–0.15±0.95	P=0.80
Østbye et al. 2012	200	200	BMI z-score	Immediately Post intervention (8 months)		Intervention (n=150)		Control (n=151)
						Baseline mean (se*)	Change mean (se*)	Baseline mean (se*)	Change mean (se*)
					BMI z-score	0.35 (0.08)	0.03 (0.05)	0.47 (0.08)	0.02 (0.05)

Table

PsycInfo	Search history	Results 2016	Results 2019
1	Overweight OR Obesity	33 079	44,562
2	Prevention	303 286	367 703
3	1 AND 2	7 113	9,817
4	2016: Published Date: 20,100,101–20,160,210 2019: Published date: 20,160,201–20,190,731 Age: 2–5 years Publication type: academic journals	341	132
5	Selected abstracts	19	21
Medline
1	Overweight OR Obesity	245,727	321,009
2	Prevention	1,384,835	1,644,312
3	1 AND 2	39,557	53,110
4	2016: Published Date: 20,100,101–20,160,231 2019: Published date: 20,160,201–20,190,731 Age: 2–5 years Publication type: academic journals	1,680	866
5	Selected abstracts	78	27
CINAHL
1	Overweight OR Obesity	80,184	112,070
2	Prevention	457,870	574,639
3	1 AND 2	18,743	25,364
4	2016: Published Date: 20,100,101–20,160,231 2019: Published date: 20,160,201–20,190,731 Age: 2–5 years Publication type: academic journals	941	208
5	Selected abstracts	120	25
Family Study Abstracts			The database was not available 2019
1	Overweight OR Obesity	602	-
2	Prevention	6,547	-
3	1 AND 2	118	-
4	Published Date: 20,100,101–20,160,231 Age: 2–5 years Publication type: academic journals	74	-
5	Selected abstracts	3	-
Embase
1	Overweight OR Obesity	388,306	566,543
2	Prevention	1,649,160	2,694,819
3	1 AND 2	54,292	89,145
4	Published Date: 20,100,101–20,160,219 Age: 2–5 years Publication type: academic journals	1924	Published date: 20,160,201–20,190,731 1,037
5	Selected abstracts	76	81

Table

Study, search 2017	Reason for exclusion
Agras, 2012	Study does not report on any of the outcomes of interest to the review
Bocca, 2014	Study does not report on any of the outcomes of interest to the review
Brotman, 2012	Had a number of methodological limitations to be considered for inclusion
Bryars, 2012	Study design was non-experimental, pre-test, post-test design
Cespedes, 2014	Only targeted overweight and obese children
Cloutier, 2015	Used a matched historic control group
Cruz, 2016	Intervention included a teacher training component
Daniels, 2013	Enrolled first-time mothers with 4-month-old infants
Daniels, 2015	Enrolled first-time mothers with 4-month-old infants
Fitzgibbon, 2011	School-based intervention and included training of teachers
Kim, 2016	Included obese and overweight children who were older than 6 years old
Koulouglioti, 2013	Study design was a one-group pre–post design
Machuca, 2016	Enrolled children up to 18 months of age
McKee, 2010	Non-random design
Natale, 2014a	Intervention was school-based and included a teacher-based component as well as environmental changes
Natale, 2014b	Intervention was school-based and included a teacher-based component as well as environmental changes
Navaro, 2013	Paired quasi-experimental design
Nyberg, 2016	Teacher training component was included in the intervention
Paul, 2011	Enrolled newborn babies
Rattanagree, 2013	Mixed methods design
Skoutiers, 2016	Enrolled children from 20 to 42 months
Taveras,	Only targeted overweight and obese children and included children from 2–6.9 years
Wen, 2015	Enrolled children aged 0–years
Whaley, 2010	Enrolled children aged 1–5 years
Study, search 2019
Cruz, 2016	Included a teacher training component
Döring, 2016	Enrolled children aged 9–10 months
Döring, 2018	Study does not report on any of the outcomes of interest to the review
Enö Persson, 2018	Enrolled children 9 months to 4 years
Haines, 2018	Enrolled children aged 1.5–5 years
Knowlden, 2018	Does not report BMI
McGowan, 2013	Does not report BMI
Mendoza, 2016	School-based
Nyström, 2017	Does not report BMI at follow-up
Taverno Ross, 2018	Non-randomized
Paul, 2018	Enrolled newborns
Poeta, 2015	Conference abstract

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from Publication: “A computer-generated permuted block randomization scheme with a block size of 10 was used … ” Comment: Appropriate
Allocation concealment (selection bias)	Low risk	Quote from publication: “A biostatistician generated the randomization list and condition assignments were placed in nontransparent envelopes, which were sealed and numbered consecutively” Comment: Appropriate
Blinding of participants	High risk	Participants were not blinded to other participants’ condition allocation
Blinding of staff	High risk	Research staff were not blinded to participants’ condition allocation
Blinding of outcome assessment (detection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Low risk	ITT was employed
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported
Other bias	Low risk	Study perceived to be free of other risks of bias

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: “A statistician flipped a coin and informed the researchers of the randomization plan” Comment: adequate
Allocation concealment (selection bias)	Low risk	The researchers were informed of the randomization plan after the coin was flipped
Blinding of participants	High risk	Due to the type of intervention, it is deemed that the participants knew the group to which they were assigned
Blinding of staff	High risk	Considering that the control group was a wait-list control group, it can thus be assumed that the researchers were not blinded to which group participants were allocated to
Blinding of outcome assessment (detection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Unclear risk	Insufficient reporting of attrition to permit judgement of “Low risk” or “High risk”
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: “Statistical programmer used a computerized routine to randomly assign the intervention and control condition” Comment: Appropriate
Allocation concealment (selection bias)	Low risk	Assignments were implemented through sealed sequentially numbered individual envelopes
Blinding of participants	Unclear risk	Participants judged as not blinded, and the outcome may likely to be influenced by the lack of blinding
Blinding of staff	High risk	It is perceived that study personnel were not blinded, and the outcome likely to be influenced by the lack of blinding
Blinding of outcome assessment (detection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	High risk	Even though it is stated that ITT was used, outcome measures reports only those who completed the follow-up
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported, therefore free of reporting bias
Other bias	High risk	Participants were not asked to keep any dairies and assessments were based on what they could remember therefore this could be a source of bias in the outcomes reported

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: “two random sequences of group allocation were developed using SPSS … ” to assign families to the two study and two control groups.
Allocation concealment (selection bias)	High risk	Parents who could attend to the initial workshop were randomized to A, B, C or D. Those who could not attend the workshop were randomized to B, C or D.
Blinding of participants	High risk	Participants were not blinded and their reports of the outcome measures may have likely been biased due to their knowledge that reducing the outcome was the aim of the study.
Blinding of staff	High risk	Staff who gave the initial session in the intervention groups were not blinded and this may have likely affected the outcome measure
Blinding of outcome assessment (detection bias)	Low risk	The instruments were distributed via email.
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Unclear risk	Loss to follow-up reported, but reasons for loss to follow-up not given and no ITT employed
Selective reporting (reporting bias)	High risk	All pre-specified outcomes reported from the 6-weeks follow up but not from the 6- and 12-month follow-up
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from Publication “Using a computer-generated randomization list designed by a US-based statistician with no connection to the intervention” Comment: Adequate
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of participants	High risk	It was judged that participants were not blinded as participants got to know of their intervention status
Blinding of staff	High risk	It was judged that study staff were not blinded to the interventions as a substitution of a clinic was made after randomization
Blinding of outcome assessment (detection bias)	High risk	study staff were not blinded to the intervention status at the 3- and 6-month follow-up assessments
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Low risk	Intent-to-treat analyses were used and further still, SAS imputations were used to account for missing data
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes have been reported
Other bias	High risk	Study perceived to be of high risk of bias as there were extreme baseline imbalances in levels of physical activity

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from Publication: “they were randomized to the study via permuted 8-block randomization, generated by SAS” Comment: Appropriate
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of participants	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of staff	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of outcome assessment (detection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Low risk	Attrition reported and reasons for loss to follow-up explained. ITT was not employed, but sensitivity analyses were also conducted, in which missing follow-up measurements were imputed to their baseline values.
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported as stated
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: “ … randomly assigned through a computer programme … ” Comment: adequate
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of participants	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of staff	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of outcome assessment (detection bias)	Low risk	outcome assessor was not aware of group assignment
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Low risk	imputation of missing data was done using a carefully constructed model that included relevant independent variables
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of participants	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of staff	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of outcome assessment (detection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported as stated
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: “Randomization was conducted at the individual level after stratification for community and child weight status.”
Allocation concealment (selection bias)	High risk	Eight families who could not be scheduled for the in-home session switched group to the control group where no in-home sessions were included.
Blinding of participants	High risk	Participants were not blinded and their reports of the outcome measures may have likely been biased due to their knowledge that reducing the outcome was the aim of the study.
Blinding of staff	High risk	Staff were not blinded
Blinding of outcome assessment (detection bias)	High risk	“Community partners” from the tribe reviewed and commented on the collected data.
Blinding of analysts	Low risk	All data were mailed to the University of Wisconsin; data entry and analysis were conducted by researchers who were blinded to group assignment.
Incomplete outcome data (attrition bias)	Unclear risk	The dropout rate was high, especially in the intervention group. (Possible reasons are discussed)
Selective reporting (reporting bias)	High risk	All outcomes for the first year is reported. As both the intervention group and the active control group improved, data for both groups combined are also reported. For year two, we can only find data for BMI.
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias exists

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: “teams were randomized for allocation to intervention or control by means of a computer-generated random number list” comment: Appropriate
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of participants	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of staff	High risk	The staff were not blinded and this may have had an effect on the outcome measure
Blinding of outcome assessment (detection bias)	High risk	Study stuff who delivered the intervention also took part in the outcome assessments hence they may not have been blinded and this could have an effect on the outcome measure
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Low risk	Loss to follow-up reported and reasons given, and Intention to treat analysis employed
Selective reporting (reporting bias)	High risk	Not all pre-specified outcomes of interest were reported
Other bias	High risk	Study is perceived to may have a high risk of bias due to possible contamination among the groups.

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: the project manager used a pseudo-random number generator to randomly assign the sessions comment: Appropriate
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Blinding of participants	High risk	Participants were not blinded and their reports of the outcome measures may have likely been biased due to their knowledge that reducing the outcome was the aim of the study.
Blinding of staff	High risk	The staff were not blinded and this may have had an effect on the outcome measure
Blinding of outcome assessment (detection bias)	Unclear risk	There is a possibility that the outcome assessors could engage in conversations with the parents and know which groups they were randomized to
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Low risk	Loss to follow-up reported and reasons given, and Intention to treat analysis employed
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes of interest were reported
Other bias	Unclear risk	Unclear due to Pseudo randomization

Table

Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: “a list of random numbers was used to assign families to study or control group” comment: appropriate
Allocation concealment (selection bias)	Unclear risk	Insufficient information provided for a clear judgement
Blinding of participants	High risk	Participants were not blinded and their reports of the outcome measures may have likely been biased due to their knowledge that reducing the outcome was the aim of the study.
Blinding of staff	High risk	Staff were not blinded and this may have likely affected the outcome measure
Blinding of outcome assessment (detection bias)	Unclear risk	Data collecting residents were uninformed about group assignment
Blinding of analysts	Unclear risk	Insufficient information to permit judgement of “Low risk” or “High risk”
Incomplete outcome data (attrition bias)	Unclear risk	Loss to follow-up reported, but reasons for loss to follow-up not given and no ITT employed
Selective reporting (reporting bias)	Low risk	All pre-specified outcomes reported
Other bias	High risk	Data collected from parents regarding TV time and aggressive behaviours are likely to be biased and thus overestimate the results given, since parents knew that reducing these two outcomes was the aim of the study

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