NCT00759746

Brief Summary

The purpose of this study is to determine the effect of dose and content of an enhanced weight maintenance treatment on children's ability to maintain weight loss following a standard weight loss treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
482

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3.4 years

First QC Date

September 23, 2008

Last Update Submit

February 20, 2017

Conditions

Keywords

Weight loss maintenance

Outcome Measures

Primary Outcomes (1)

  • Child percent overweight

    1 year

Study Arms (3)

Weight Maintenance Education

ACTIVE COMPARATOR

Participants assigned to this group will receive the Weight Maintenance Education intervention. They will meet every other week during the maintenance phase of the study for a total of 16 sessions over 8 months. During the visit, participants will participate in a series of interactive workshops within child and parent groups to learn general information about healthy eating and physical activity.

Behavioral: Weight Maintenance Education

SFM+ Low Dose

EXPERIMENTAL

Participants assigned to this group will receive the SFM+ Low Dose.

Behavioral: SFM+ Low Dose

SFM+ High Dose

EXPERIMENTAL

Participants assigned to this group will receive the SFM+ High Dose.

Behavioral: SFM+ High Dose

Interventions

SFM+ Low DoseBEHAVIORAL

The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance. Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers). Participants in this group will meet less often than families that receive the Social Facilitation Maintenance (SFM) - High Dose intervention, giving them more opportunities to practice new skills between clinic visits.

SFM+ Low Dose

The Weight Maintenance Education intervention will help participants in parent and child groups to learn more about healthy eating and physical activity in a group setting. Participants will also learn about exercise and exercise safety, hydration during exercise, and stress management. Parent and child groups will combine for particular on-site and off-site activities, such as cooking demonstrations, grocery store tours, gym tours, and dance lessons.

Weight Maintenance Education
SFM+ High DoseBEHAVIORAL

The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance. Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers). Participants in this group will meet more often than families that receive the Social Facilitation Maintenance (SFM) - Low Dose intervention, allowing for more in-depth discussion and practice of key skills and concepts related to creating a social environment that supports a healthy lifestyle. These participants will receive more feedback and reinforcement from fellow group members, family interventionists, and group leaders for practicing their new behaviors.

SFM+ High Dose

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children will be between the ages of 7 and 11 and at or above the 85th percentile for weight.
  • At least one parent of the participating child must be overweight (BMI ≥ 25).
  • One parent must agree to attend all parent/child treatment meetings as the participating parent.
  • Participants must be able to speak and comprehend English.

You may not qualify if:

  • Participating parent or child having a thought disorder, suicidality, bipolar disorder, or drug or alcohol dependence.
  • Participating parent or child having a physical disability or illness that prevents performance of physical activity at level equivalent to a brisk walk or that places severe restriction on diet.
  • Participating parent or child being on a medication regimen that affects weight.
  • Participating parent or child being involved in active psychiatric treatment for an ongoing problem that causes either social or occupational impairment.
  • Parents (participating and nonparticipating) and children having an eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or having subclinical levels of eating disturbance (i.e., reporting key eating disorder behaviors of purging, fasting, or binge eating more than two times per month).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Seattle Children's Hospital Research Institute

Seattle, Washington, 98121, United States

Location

Related Publications (10)

  • Hayes JF, Altman M, Kolko RP, Balantekin KN, Holland JC, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Decreasing food fussiness in children with obesity leads to greater weight loss in family-based treatment. Obesity (Silver Spring). 2016 Oct;24(10):2158-63. doi: 10.1002/oby.21622. Epub 2016 Sep 7.

  • Altman M, Cahill Holland J, Lundeen D, Kolko RP, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Reduction in food away from home is associated with improved child relative weight and body composition outcomes and this relation is mediated by changes in diet quality. J Acad Nutr Diet. 2015 Sep;115(9):1400-7. doi: 10.1016/j.jand.2015.03.009. Epub 2015 May 8.

  • Holland JC, Kolko RP, Stein RI, Welch RR, Perri MG, Schechtman KB, Saelens BE, Epstein LH, Wilfley DE. Modifications in parent feeding practices and child diet during family-based behavioral treatment improve child zBMI. Obesity (Silver Spring). 2014 May;22(5):E119-26. doi: 10.1002/oby.20708. Epub 2014 Mar 25.

  • Best JR, Theim KR, Gredysa DM, Stein RI, Welch RR, Saelens BE, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Behavioral economic predictors of overweight children's weight loss. J Consult Clin Psychol. 2012 Dec;80(6):1086-1096. doi: 10.1037/a0029827. Epub 2012 Aug 27.

  • Fowler LA, Litt MD, Rotman SA, Conlon RPK, Jakubiak J, Stein RI, Balantekin KN, Welch RR, Perri MG, Epstein LH, Wilfley DE. Relation of social network support to child health behaviors among children in treatment for overweight/obesity. Eat Weight Disord. 2022 Jun;27(5):1669-1678. doi: 10.1007/s40519-021-01303-4. Epub 2021 Sep 21.

  • Grammer AC, Best JR, Fowler LA, Balantekin KN, Stein RI, Conlon RPK, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. General and Eating Disorder Psychopathology in Relation to Short- and Long-Term Weight Change in Treatment-Seeking Children: A Latent Profile Analysis. Ann Behav Med. 2021 Jun 28;55(7):698-704. doi: 10.1093/abm/kaaa076.

  • Fowler LA, Grammer AC, Ray MK, Balantekin KN, Stein RI, Kolko Conlon RP, Welch RR, Perri MG, Epstein LH, Wilfley DE. Examining the interdependence of parent-child dyads: Effects on weight loss and maintenance. Pediatr Obes. 2021 Jan;16(1):e12697. doi: 10.1111/ijpo.12697. Epub 2020 Jul 28.

  • Rotman SA, Fowler LA, Ray MK, Stein RI, Hayes JF, Kolko RP, Balantekin KN, Engel A, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. Family Encouragement of Healthy Eating Predicts Child Dietary Intake and Weight Loss in Family-Based Behavioral Weight-Loss Treatment. Child Obes. 2020 Apr;16(3):218-225. doi: 10.1089/chi.2019.0119. Epub 2019 Dec 12.

  • Wilfley DE, Saelens BE, Stein RI, Best JR, Kolko RP, Schechtman KB, Wallendorf M, Welch RR, Perri MG, Epstein LH. Dose, Content, and Mediators of Family-Based Treatment for Childhood Obesity: A Multisite Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1151-1159. doi: 10.1001/jamapediatrics.2017.2960.

  • Balantekin KN, Hayes JF, Sheinbein DH, Kolko RP, Stein RI, Saelens BE, Hurst KT, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Patterns of Eating Disorder Pathology are Associated with Weight Change in Family-Based Behavioral Obesity Treatment. Obesity (Silver Spring). 2017 Dec;25(12):2115-2122. doi: 10.1002/oby.22028. Epub 2017 Oct 6.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Denise E Wilfley, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Brian Saelens, Ph.D.

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

October 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations