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

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ClinicalTrials.gov Identifier: NCT03961061
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Weight Change, Body Behavior, Health Obesity, Childhood Parent-Child Relations Behavioral: Brenner mFIT (standard care) Behavioral: Brenner mFIT (standard care plus mobile health components) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The control group will receive standard Brenner FIT care. The intervention group will receive standard Brenner FIT care in additional to mobile health components in the hopes of maximizing the benefits that are already seen with pediatric weight management programs like Brenner FIT.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increased Monitoring of Physical Activity and Calories With Technology
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.


  5. 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.


  6. 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.


  7. 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.

  8. 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.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961061


Contacts
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Contact: Justin Moore, PhD 336-716-3702 jusmoore@wakehealth.edu
Contact: Camelia R Singletary, MPH 13369992469 crsingle@wakehealth.edu

Locations
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United States, North Carolina
Brenner Children's Hospital Recruiting
Winston-Salem, North Carolina, United States, 27127
Contact: Joseph Skelton, MD    336-716-9354    jskelton@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Justin B Moore, PhD Wake Forest Baptist Medical Center
More Information
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Publications:
Djafarian K, Speakman JR, Stewart J, Jackson DM. Comparison of activity levels measured by a wrist worn accelerometer and direct observation in young children. Open Journal of Pediatrics. 2013;03(04):422-427. 162.
Chandler JL, Beets MW, Drenowatz C, et al. The Rosetta Stone for equating hip and wrist- based accelerometer derived estimates of physical activity among elementary aged youth. Under review.
Chandler JL, Beets MW, Drenowatz C, et al. Analysis of Accelerometer Counts during Sedentary Activities on Dominant and Non-Dominant Wrists in 5-11 year old Children. Under review.
Sallis JF, Pinski RB, Grossman RM, Patterson TL, Nader PR. The development of self-efficacy scales for health related diet and exercise behaviors. Health Education Research. 1988;3(3):283-292.
Kendall P, Williams CL. Assessing the cognitive and behavioral components of children's selfmanagement. In: Karoly P, Kanfer F, eds. Self-Management and Behavior Change. New York: Pergamon Press; 1982.
Heiby EM. Assessment of Frequency of Self-Reinforcement. Journal of Personality and Social Psychology. 1983;44(6):1304-1307.
Deci EL, Schwartz AJ, Sheinman L, Ryan RM. An Instrument to Assess Adults Orientations toward Control Versus Autonomy with Children - Reflections on Intrinsic Motivation and Perceived Competence. Journal of Educational Psychology. 1981;73(5):642-650.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03961061    
Other Study ID Numbers: IRB00058207
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
weight management
pediatric weight management
mHealth
 mobile technology
parent/child relations
dyad
Additional relevant MeSH terms:
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Pediatric Obesity
Body Weight Changes
Body Weight
Obesity
 Overnutrition
Nutrition Disorders
Overweight