TY - JOUR
T1 - Dose, content, and mediators of family-based treatment for childhood obesity a multisite randomized clinical trial
AU - Wilfley, Denise E.
AU - Saelens, Brian E.
AU - Stein, Richard I.
AU - Best, John R.
AU - Kolko, Rachel P.
AU - Schechtman, Kenneth B.
AU - Wallendorf, Michael
AU - Robinson Welch, R.
AU - Perri, Michael G.
AU - Epstein, Leonard H.
N1 - Funding Information:
Funding/Support: This study was funded by the National Institute of Child Health and Human Development (NICHD) (grant R01HD036904 to Dr Wilfley); National Institute of Mental Health (grant K24MH070446 to Dr Wilfley); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (grant K23DK060476 to Dr Saelens); National Center for Research Resources (NCRR) (grants KL2RR024994 [Dr Stein], UL1RR024992, and UL1RR025014); National Heart, Lung, and Blood Institute (grant T32HL007456 to Dr Kolko); the NIDDK Nutrition Obesity Research Center (grant P30DK056341); National Center for Advancing Translational Sciences (University of Washington Clinical and Translational Science Award) of the National Institutes of Health (grants UL1TR000448 and UL1TR000423); St. Louis Children’s Hospital Foundation (Washington University Pediatric and Adolescent Research Consortium); and institutional support from Washington University School of Medicine and Seattle Children’s Research Institute.
Publisher Copyright:
© 2017 American Medical Association. All rights reserved.
PY - 2017/12
Y1 - 2017/12
N2 - IMPORTANCE Elucidation of optimal dosing and treatment content is critical for health care providers, payers, and policy makers, as well as mechanisms of change to inform intervention delivery and training initiatives for childhood obesity. OBJECTIVES To evaluate effects, following a 4-month family-based behavioral weight loss treatment (FBT), of 2 doses (HIGH or LOW) of a weight-control intervention (enhanced social facilitation maintenance [SFM+]) vs a weight-control education condition (CONTROL; matched for dose with LOW), on child anthropometrics, and to explore putative mediators of weight loss outcomes. DESIGN, SETTING, AND PARTICIPANTS For this parallel-group randomized clinical trial conducted at 2 US academic medical centers from December 2009 to March 2013, 172 parent-child dyads completed FBT and were then randomized to 8 months of SFM+ (HIGH, n = 59; LOW, n = 56) or CONTROL (n = 57). Children (aged 7-11 years) with overweight and obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] 85th percentile) with at least 1 parent with overweight and obesity (BMI 25) were recruited. INTERVENTIONS HIGH SFM+ vs LOW SFM+ (CONTROL matched the dose of LOW). MAIN OUTCOMES AND MEASURES Intention-to-treat analysis using mixed-effects models estimated change in child percentage overweight (percentage above the median BMI for a child's age and sex) for the FBT period (0-4 months) and the SFM+ period (4-12 months), and proportion of children achieving a clinically significant change in percentage overweight (9-unit decrease; months 0-12). Theory-based outcome mediators were also evaluated. RESULTS This study recruited 172 parent-child dyads (mean [SD] age: parents 42.3 [6.4] years; children, 9.4 [1.3] years). The omnibus treatment × time interaction for child percentage overweight was significant (F8, 618.9 = 2.89; P = .004). Planned pairwise comparisons revealed that from months 4 to 12, LOW had better outcomes than CONTROL (difference, -3.34; 95% CI, -6.21 to -0.47; d = -0.40; P = .02). HIGH had better outcomes than LOW (difference, -3.37; 95% CI, -6.15 to -0.59; d = -0.38; P = .02) and CONTROL (difference, -6.71; 95% CI, -9.57 to -3.84; d = -0.77; P < .001). A greater proportion of children in HIGH (45 [82%]) vs LOW (34 [64%]) (difference, 18.00; 95% CI, 1.00-34.00; P = .03; number needed to treat = 5.56) and CONTROL (25 [48%]) (difference, 34.00; 95% CI, 16.00-51.00; P < .001; number needed to treat = 2.94) had clinically significant percentage overweight reductions. Food and activity monitoring and goal setting mediated the effect of LOW vs CONTROL (50%). Monitoring and goal setting, family and home environment, and healthy behaviors with peers mediated the effect of HIGH vs CONTROL (25%-42%). CONCLUSIONS AND RELEVANCE Following FBT, specialized intervention content (SFM+) enhanced children’s weight outcomes and outperformed a credible control condition, with high dose delivery yielding the best outcomes. Sustained monitoring and goal setting, support from the family and home environment, and healthy peer interactions explained outcome differences, highlighting key treatment targets.
AB - IMPORTANCE Elucidation of optimal dosing and treatment content is critical for health care providers, payers, and policy makers, as well as mechanisms of change to inform intervention delivery and training initiatives for childhood obesity. OBJECTIVES To evaluate effects, following a 4-month family-based behavioral weight loss treatment (FBT), of 2 doses (HIGH or LOW) of a weight-control intervention (enhanced social facilitation maintenance [SFM+]) vs a weight-control education condition (CONTROL; matched for dose with LOW), on child anthropometrics, and to explore putative mediators of weight loss outcomes. DESIGN, SETTING, AND PARTICIPANTS For this parallel-group randomized clinical trial conducted at 2 US academic medical centers from December 2009 to March 2013, 172 parent-child dyads completed FBT and were then randomized to 8 months of SFM+ (HIGH, n = 59; LOW, n = 56) or CONTROL (n = 57). Children (aged 7-11 years) with overweight and obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] 85th percentile) with at least 1 parent with overweight and obesity (BMI 25) were recruited. INTERVENTIONS HIGH SFM+ vs LOW SFM+ (CONTROL matched the dose of LOW). MAIN OUTCOMES AND MEASURES Intention-to-treat analysis using mixed-effects models estimated change in child percentage overweight (percentage above the median BMI for a child's age and sex) for the FBT period (0-4 months) and the SFM+ period (4-12 months), and proportion of children achieving a clinically significant change in percentage overweight (9-unit decrease; months 0-12). Theory-based outcome mediators were also evaluated. RESULTS This study recruited 172 parent-child dyads (mean [SD] age: parents 42.3 [6.4] years; children, 9.4 [1.3] years). The omnibus treatment × time interaction for child percentage overweight was significant (F8, 618.9 = 2.89; P = .004). Planned pairwise comparisons revealed that from months 4 to 12, LOW had better outcomes than CONTROL (difference, -3.34; 95% CI, -6.21 to -0.47; d = -0.40; P = .02). HIGH had better outcomes than LOW (difference, -3.37; 95% CI, -6.15 to -0.59; d = -0.38; P = .02) and CONTROL (difference, -6.71; 95% CI, -9.57 to -3.84; d = -0.77; P < .001). A greater proportion of children in HIGH (45 [82%]) vs LOW (34 [64%]) (difference, 18.00; 95% CI, 1.00-34.00; P = .03; number needed to treat = 5.56) and CONTROL (25 [48%]) (difference, 34.00; 95% CI, 16.00-51.00; P < .001; number needed to treat = 2.94) had clinically significant percentage overweight reductions. Food and activity monitoring and goal setting mediated the effect of LOW vs CONTROL (50%). Monitoring and goal setting, family and home environment, and healthy behaviors with peers mediated the effect of HIGH vs CONTROL (25%-42%). CONCLUSIONS AND RELEVANCE Following FBT, specialized intervention content (SFM+) enhanced children’s weight outcomes and outperformed a credible control condition, with high dose delivery yielding the best outcomes. Sustained monitoring and goal setting, support from the family and home environment, and healthy peer interactions explained outcome differences, highlighting key treatment targets.
UR - http://www.scopus.com/inward/record.url?scp=85038224407&partnerID=8YFLogxK
U2 - 10.1001/jamapediatrics.2017.2960
DO - 10.1001/jamapediatrics.2017.2960
M3 - Article
C2 - 29084318
AN - SCOPUS:85038224407
SN - 2168-6203
VL - 171
SP - 1151
EP - 1159
JO - JAMA Pediatrics
JF - JAMA Pediatrics
IS - 12
ER -