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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: child health education; Behavioral: skills training

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19716
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Child Health Education; 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.	Behavioral: child health education; 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.
Experimental: Skills Training; 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.	Behavioral: skills training; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy intake	Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days.	3-months
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.	3-months
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.	3-months
Physical Activity	Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR.	3-months

Collaborators and Investigators

• Sponsor: University of Delaware
• Investigators: Principal Investigator: Shannon Robson, PhD, MPH, RD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 5, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 906996-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No