Back to resultsSkills Training Within a Family-based Obesity Treatment Intervention
Primary Purpose
Obesity, Childhood
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
child health education
skills training
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
the child has a medical condition impacting physical activity or eating (e.g. Type
1 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.
Sites / Locations
- University of Delaware
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Child Health Education
Skills Training
Arm Description
The 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.
The 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Energy intake
Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days.
Percent Energy from Fat
Based upon a 3-day dietary record analyzed using NDS-R, the calories from fat will be divided by total energy intake (calories) to get percentage energy from fat.
Food groups servings
Based upon a 3-day dietary record analyzed using NDS-R, the number of servings consumed from each food group will be averaged over three days.
Physical Activity
Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03271801
Brief Title
Skills Training Within a Family-based Obesity Treatment Intervention
Official Title
Skills Training in Stimulus Control of Meals and Snacks Within a Family-based Obesity Treatment Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment Challenges
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Family-based obesity treatment interventions can successfully reduce weight in children, but are often limited in the practice of skills being taught during treatment sessions.
Skills training focused on a particular behavioral strategy can provide parents with an experiential component of learning where the information learned as part of a family-based obesity treatment intervention is also practiced. Health education simply provides knowledge to a family about a topic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Child Health Education
Arm Type
Active Comparator
Arm Description
The 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.
Arm Title
Skills Training
Arm Type
Experimental
Arm Description
The 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.
Intervention Type
Behavioral
Intervention Name(s)
child health education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
skills training
Intervention Description
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).
Primary Outcome Measure Information:
Title
z-BMI
Description
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.
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Energy intake
Description
Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days.
Time Frame
3-months
Title
Percent Energy from Fat
Description
Based upon a 3-day dietary record analyzed using NDS-R, the calories from fat will be divided by total energy intake (calories) to get percentage energy from fat.
Time Frame
3-months
Title
Food groups servings
Description
Based upon a 3-day dietary record analyzed using NDS-R, the number of servings consumed from each food group will be averaged over three days.
Time Frame
3-months
Title
Physical Activity
Description
Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR.
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
the child has a medical condition impacting physical activity or eating (e.g. Type
1 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Robson, PhD, MPH, RD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Skills Training Within a Family-based Obesity Treatment Intervention
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