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Skills Training Within a Family-based Obesity Treatment Intervention
Skills Training in Stimulus Control of Meals and Snacks Within a Family-based Obesity Treatment Intervention
1 other identifier
interventional
2
1 country
1
Brief Summary
This study is investigating the impact of a skills training program in stimulus control of meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity treatment intervention with education on child health or a standard family-based obesity treatment intervention with experiential learning about meal stimulus control strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedMarch 26, 2019
March 1, 2019
2.7 years
March 29, 2017
March 22, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
z-BMI
Height and weight will be used to calculate BMI (kg/m2) and BMI will be standardized in relation to the population mean and standard deviation for the child's age to sex to determine zBMI.
3-months
Secondary Outcomes (4)
Energy intake
3-months
Percent Energy from Fat
3-months
Food groups servings
3-months
Physical Activity
3-months
Study Arms (2)
Child Health Education
ACTIVE COMPARATORThe child health education condition will participate in a family-based obesity treatment program for the first 40 minutes of each session, followed by 20 minutes designated to education about a child health topic. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time.
Skills Training
EXPERIMENTALThe skills training condition will participate in a family-based obesity treatment program for the first 40 minutes of each session followed by 20 minutes of experiential learning about meal stimulus control strategies. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time. In addition they will self-monitor the use the following stimulus control strategies: portion control, energy density and variety.
Interventions
10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of education about a child health topic.
10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of experiential learning about stimulus control strategies (portion size, energy density, variety).
Eligibility Criteria
You may qualify if:
- caregiver of child is ≥18 years of age;
- the caregiver has a child between the ages of 4 and 8 years-old who is classified as overweight (body mass index for age ≥ 85th percentile);
- the caregiver and child are able to read, speak and understand English due to delivery of the program in English;
- has transportation to the University of Delaware; and
- is willing and able to commit to the 3-month study.
You may not qualify if:
- the child has a medical condition impacting physical activity or eating (e.g. Type
- or Type 2 diabetes);
- the child have a medical condition that affects growth (e.g. Prader Willi Syndrome);
- the child is currently participating in a weight management program, and/or taking weight loss medication; or
- the caregiver or child has an inability to participate in regular physical activity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Delaware
Newark, Delaware, 19716, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Robson, PhD, MPH, RD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 29, 2017
First Posted
September 5, 2017
Study Start
June 1, 2016
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
March 26, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share