Increased Monitoring of Physical Activity and Calories With Technology

NCT03961061 | Completed Results

• 2 other identifiers: IRB00058207R34DK119815
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Change, Body; Behavior, Health; Obesity, Childhood; Parent-Child Relations

Keywords

weight management; pediatric weight management; mHealth; mobile technology; parent/child relations; dyad

Outcome Measures

Primary Outcomes (3)

• BMI Percentile

  The weight status of youth will be quantified through the calculation of BMI derived from the 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 digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a "healthy weight," over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.

  Baseline

• BMI Percentile

  The weight status of youth will be quantified through the calculation of BMI derived from the 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 digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a "healthy weight," over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.

  3 months

• BMI Percentile

  The weight status of youth will be quantified through the calculation of BMI derived from the 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 digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a "healthy weight," over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.

  6 months

Secondary Outcomes (7)

• Physical Activity Via Accelerometry (Bouts of Physical Activity)

  Baseline

• Physical Activity Via Accelerometry (Bouts of Physical Activity)

  3 months

• Physical Activity Via Accelerometry (Bouts of Physical Activity)

  6 months

• ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool

  Baseline

• ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool

  3 months

Study Arms (2)

Brenner FIT (Standard Care)

ACTIVE COMPARATOR

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)

Brenner mFIT (standard care plus mobile health components)

EXPERIMENTAL

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)

Interventions

Brenner mFIT (standard care) BEHAVIORAL

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.

Brenner FIT (Standard Care)

Brenner mFIT (standard care plus mobile health components) BEHAVIORAL

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.

Brenner mFIT (standard care plus mobile health components)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brenner Children's Hospital

Winston-Salem, North Carolina, 27127, United States

Location

Related Publications (42)

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  BACKGROUND

MeSH Terms

Conditions

Body Weight Changes; Health Behavior; Pediatric Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Due to the COVID-19 pandemic, participants did not provide three-month anthropometric, physical activity, or dietary data, and participation in six-month follow-up data collection was extremely low.

Results Point of Contact

• Title: Justin B. Moore, PhD
• Organization: Wake Forest Health Sciences

jusmoore@wakehealth.edu

336-716-3702

Study Officials

• Justin B Moore, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: November 4, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)