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OpenTrials
Completed

NCT Number: NCT03961061

Increased Monitoring of Physical Activity and Calories With Technology

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.

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Key information

Conditions

Weight Change, Body Behavior Behavior, Health Body Weight Body Weight Changes Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Childhood Overnutrition Overweight Parent-Child Relations Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brenner Children's Hospital

Winston-Salem, North Carolina, 27127, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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-

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

Primary outcomes

  1. BMI Percentile

    Time frame: Baseline

    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.

  2. BMI Percentile

    Time frame: 3 months

    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. BMI Percentile

    Time frame: 6 months

    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.

Secondary outcomes

  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 Two Intervention Arms

    Time frame: Through study completion (6 months)

    Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: IMPACT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 23, 2019
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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