Skills Training Within a Family-based Obesity Treatment Intervention

Obesity, Childhood Clinical Trial

Official title:

Skills Training in Stimulus Control of Meals and Snacks Within a Family-based Obesity Treatment Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03271801
• Other study ID #: 906996-1
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

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