Increased Monitoring of Physical Activity and Calories With Technology

Obesity, Childhood Clinical Trial

— IMPACT  

Official title:

Increased Monitoring of Physical Activity and Calories With Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961061
• Other study ID #: IRB00058207
• Status: Completed
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Health
• Body Weight Changes
• Obesity, Childhood
• Parent-Child Relations
• Pediatric Obesity
• Weight Change, Body

Intervention

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.
• 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- 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.

Locations

Country	Name	City	State
United States	Brenner Children's Hospital	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score	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
Primary	BMI z-score	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
Primary	BMI z-score	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	Physical activity via accelerometry (bouts of physical activity)	Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.	Baseline
Secondary	Physical activity via accelerometry (bouts of physical activity)	Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.	3 months
Secondary	Physical activity via accelerometry (bouts of physical activity)	Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.	6 months
Secondary	ASA24 Automated Self Administered 24 hour dietary assessment tool	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
Secondary	ASA24 Automated Self Administered 24 hour dietary assessment tool	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
Secondary	ASA24 Automated Self Administered 24 hour dietary assessment tool	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
Secondary	Economic costs of the mHealth intervention costs	Clinical costs of the mHealth intervention will be compiled over the duration of the program.	Baseline
Secondary	Economic costs of the mHealth intervention costs	Clinical costs of the mHealth intervention will be compiled over the duration of the program.	3 months
Secondary	Economic costs of the mHealth intervention costs	Clinical costs of the mHealth intervention will be compiled over the duration of the program.	6 months