NCT03271801

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

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

March 29, 2017

Last Update Submit

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 COMPARATOR

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

Skills Training

EXPERIMENTAL

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

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.

Child Health Education
skills trainingBEHAVIORAL

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).

Skills Training

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shannon Robson, PhD, MPH, RD

    University of Delaware

    PRINCIPAL INVESTIGATOR

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

Locations