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Virtual Health Focused Acceptance-Based Program for Parents and Youth (vHAPPY)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Pediatric Obesity
Executive Function

Treatments

Behavioral: Web Based Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04634045
300005967

Details and patient eligibility

About

The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to (1) Transition a previously developed acceptance-based behavioral treatment to web-based platform, utilizing qualitative and quantitative program evaluation data from past participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment (self-guided treatment + brief coaching) is similar to the traditional treatment (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary outcomes utilizing a non-randomized sequential arm design.

Full description

Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle program including education on health and wellness topics such as food groups, physical activity and stress management. Special skill builders for managing the thoughts, feelings and emotions associated with changing health behaviors will also be included. Pairs will have biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and problem solve. Optional group sessions will be offered for peer support. In order to assess progress, pairs will also complete assessment visits before and after the program. These visits include one virtual assessment via Zoom and one in-person assessment at the University of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures such has height, weight, blood pressure and a finger prick.

Enrollment

19 patients

Sex

All

Ages

8 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children who:

  1. have a BMI ≥ 85th percentile;
  2. are 8 and 14 years old at the beginning of treatment;
  3. can read, write, and speak English, along with their caregiver;
  4. plan to stay living in the local area during the study period;
  5. have a consenting caregiver who can commit to all study procedures.

Exclusion criteria

Children who:

  1. have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function;
  2. are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

Web-Based Treatment
Experimental group
Description:
A web-based treatment for pediatric overweight or obesity will be piloted with 10 caregiver and child pairs. Assessments will take place pre (0 months), post intervention (3.5 months) and at six months post-intervention (9.5 months) to evaluate patient outcomes, acceptability and feasibility.
Treatment:
Behavioral: Web Based Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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