Increased Monitoring of Physical Activity and Calories With Technology (IMPACT)

June 1, 2023 updated by: Wake Forest University Health Sciences
Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the Brenner Families in Training (FIT) group or the Brenner Families in Training Mobile (mFIT) group. All youth participants will receive a commercially available activity monitor. Caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. Children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. All participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. The proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27127
        • Brenner Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in Brenner Families in Training (FIT). Caregivers must live in the home with their youth participants. Obesity is defined a BMI (35.9 +/- 8.6). Participants must also have access to a smartphone or tablet

Exclusion Criteria:

Adolescents under the age of 13 will be excluded. If participants do not have access to a smartphone or tablet, they will not be able to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Brenner FIT (Standard Care)
Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments.
Behavioral: Brenner mFIT (standard care)
Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.
Experimental: Brenner mFIT (standard care plus mobile health components)

Adolescents will participate in Brenner Families in Training along with their caregiver.

Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT
Behavioral: Brenner mFIT (standard care plus mobile health components)

Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components.

The six mHealth components that will be used in addition to standard Brenner Families in Training program include-

  1. a mobile-enabled website,
  2. diet and physical activity tracking apps and physical activity tracker
  3. tailored self-monitoring feedback
  4. caregiver podcasts
  5. animated videos for adolescent patients
  6. social support via social media.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI z-score
Time Frame: Baseline
Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus/ minus 0.1 cm) and weight (plus/minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita(registered trademark) digital scale and a Seca(registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
Baseline
BMI z-score
Time Frame: 3 months
Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus/ minus 0.1 cm) and weight (plus/minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita(registered trademark) digital scale and a Seca(registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
3 months
BMI z-score
Time Frame: 6 months
Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus/ minus 0.1 cm) and weight (plus/minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita(registered trademark) digital scale and a Seca(registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity via accelerometry (bouts of physical activity)
Time Frame: Baseline
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
Baseline
Physical activity via accelerometry (bouts of physical activity)
Time Frame: 3 months
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
3 months
Physical activity via accelerometry (bouts of physical activity)
Time Frame: 6 months
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
6 months
ASA24 Automated Self Administered 24 hour dietary assessment tool
Time Frame: Baseline

To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day).

Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
Baseline
ASA24 Automated Self Administered 24 hour dietary assessment tool
Time Frame: 3 months

To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day).

Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
3 months
ASA24 Automated Self Administered 24 hour dietary assessment tool
Time Frame: 6 months

To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day).

Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
6 months
Economic costs of the mHealth intervention costs
Time Frame: Baseline
Clinical costs of the mHealth intervention will be compiled over the duration of the program.
Baseline
Economic costs of the mHealth intervention costs
Time Frame: 3 months
Clinical costs of the mHealth intervention will be compiled over the duration of the program.
3 months
Economic costs of the mHealth intervention costs
Time Frame: 6 months
Clinical costs of the mHealth intervention will be compiled over the duration of the program.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Justin B Moore, PhD, Wake Forest Baptist Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00058207

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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