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TerminatedNCT03271801Updated Mar 26, 2019

Skills Training Within a Family-based Obesity Treatment Intervention

An interventional study of child health education and skills training in Obesity, Childhood, sponsored by University of Delaware. Terminated at 1 site in United States. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by University of Delaware · Not applicable, Interventional, and Treatment

Why this study was terminated
Recruitment Challenges
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity, Childhood
03

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Behavioralchild 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.

  • Behavioralskills 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).

05

What researchers measure

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.

    Time frame: 3-months

Secondary outcomes

  1. Energy intake

    Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days.

    Time frame: 3-months

  2. 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.

    Time frame: 3-months

  3. 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.

    Time frame: 3-months

  4. Physical Activity

    Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR.

    Time frame: 3-months

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Study locations

1 site
  • University of Delaware
    Newark, Delaware 19716, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03271801
Lead sponsor
University of Delaware
Responsible party
Shannon Robson (Assistant Professor, University of Delaware) — Principal investigator
First posted
Sep 5, 2017
Start date
Jun 1, 2016
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Mar 26, 2019

Study contacts

Shannon Robson, PhD, MPH, RD
principal investigator · University of Delaware

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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