Family Fit App for Preventing Weight Gain

Overseen By Trish Wright, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Structured programs, Eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using weight loss medications.

What data supports the effectiveness of the Family Fit treatment for preventing weight gain?

Research shows that mobile health apps and digital interventions can help manage weight by promoting healthy eating and physical activity. Additionally, using devices like Fitbits can make tracking physical activity easier and more comfortable, which may support weight management efforts. ^{1 2 3 4 5}

Is the Family Fit App safe for use in humans?

Research on Fitbit devices, which are part of the Family Fit App, shows they are generally safe for use in children and adults, including those with chronic health conditions. These devices are non-invasive and have been used successfully in various studies without significant safety concerns. ^{5 6 7 8 9}

How does the Family Fit App treatment differ from other treatments for preventing weight gain?

The Family Fit App treatment is unique because it combines the use of activity trackers like Fitbit with a family-centered approach, involving both parents and children in setting goals and monitoring physical activity. This approach is novel as it targets the whole family rather than individuals, aiming to increase physical activity collectively, which is not commonly addressed in other weight gain prevention treatments. ^{4 5 9 10 11}

What is the purpose of this trial?

The overall aim of this study is to test the acceptability and usability of a mobile application (app) for family-based physical activity and weight gain prevention among parent/guardian and child (ages 9-12 years) dyads.

Research Team

Danielle E Jake-Schoffman, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for parent-child pairs where the child is aged 9-12. Parents should be between 18-65, use a mobile device with internet, have Facebook, and live near UF campus. Both must speak English, lead sedentary lifestyles (adults <150 min/week of moderate activity or children <6 days/week of an hour of physical activity), and be able to do physical activities.

Inclusion Criteria

Child and parent must be able to speak and read English

You can understand and communicate in English.

You don't do enough physical activity each week. For adults, that means less than 150 minutes of moderate activity or less than 75 minutes of vigorous activity. For children, it means less than 6 days of 60 minutes of moderate to vigorous activity per week.

Exclusion Criteria

Parent currently participating in a structured physical activity or weight loss program (children playing sports will be permitted)

Parent currently enrolled in a research study focused on changing diet or physical activity

Child currently using Fitbit (or similar physical activity device)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Baseline Assessment

Participants complete a study orientation webinar, baseline visit, online questionnaires, and 7-days of accelerometry monitoring

1 week

1 visit (virtual)

Intervention

Participants receive Fitbits and study apps, and engage in a 12-week family-based physical activity program

12 weeks

Remote participation

Follow-up

Participants attend an in-person assessment visit, complete online questionnaires, 7 days of accelerometry, and a semi-structured interview via Zoom

1 week

1 visit (in-person), 1 visit (virtual)

Sustainability

Use of Family Fit app, Fitbit app, and Fitbit devices from weeks 13-18 to assess long-term engagement

6 weeks

Treatment Details

Interventions

• Family Fit Condition
• Fitbit Only Condition

Trial Overview The study tests a mobile app designed to encourage family-based physical activity and prevent weight gain. Participants will either use the 'Family Fit' app together or just a Fitbit device to track their fitness goals.

Participant Groups

Group I: Family Fit Condition (Intervention) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The study involved 20 children and adolescents with obesity, who were randomized to either an mHealth intervention group using the Mandolean app or a control group receiving usual care, but faced a high attrition rate of 63% in the intervention group compared to 25% in the control group.

Low engagement with the Mandolean app and perceived task burden were significant barriers to adherence, suggesting that while self-monitoring tools like the myBigO app and smartwatches were acceptable, further improvements in the usability and acceptability of the Mandolean intervention are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. Browne, S., Kechadi, MT., O'Donnell, S., et al.[2021]

A systematic review of 55 randomized controlled trials involving 3406 records found that technology-based interventions for treating pediatric obesity resulted in a small but significant weight loss effect (effect size d = -0.13), although many studies did not show significant differences compared to control groups.

In contrast, prevention interventions using technology did not demonstrate a significant impact on weight outcomes, indicating that more research is needed to assess their effectiveness compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing technological solutions for childhood obesity prevention and treatment: a systematic review and meta-analysis of current applications. Fowler, LA., Grammer, AC., Staiano, AE., et al.[2023]

Self-reported weights in a weight loss trial showed increasing underestimation over time, with an average difference of -0.5 kg at 6 months and -1.1 kg at 24 months, indicating that participants were less accurate in reporting their weights as the study progressed.

Participants who accurately reported their weights were more likely to achieve the weight loss goal, with a 9% misclassification rate in achieving the 5% weight loss goal when using self-reported weights compared to clinic measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. Jerome, GJ., Dalcin, A., Coughlin, JW., et al.[2022]

Fitbit devices are feasible for monitoring physical activity in children and adolescents with chronic health conditions, potentially improving their overall wellbeing and physical health.

However, the accuracy of Fitbit data is not sufficiently supported by evidence, suggesting that while they can be useful for general health tracking, medical-grade technologies are recommended for collecting precise health data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Fitbit devices among children and adolescents with chronic health conditions: a scoping review. Kasparian, AM., Badawy, SM.[2022]

A review of 370 smartphone apps for child nutrition identified 33 that qualified for analysis, revealing that many lack updated information and do not cite their sources, which raises concerns about the reliability of the guidance provided to parents.

Only a small number of apps offer expert consultations or specific nutrient requirements, indicating a lack of uniform guidelines in the development of these applications, which could affect their effectiveness in supporting child nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. Srivastava, R., Kushwaha, S., Khanna, P., et al.[2022]

Medical students using activity trackers combined with weekly email communication (Fitbit-Plus group) significantly increased their daily step count compared to those using only the trackers (Fitbit-Only group), with an average of 7429 steps versus 6483 steps over the academic year.

The Fitbit-Plus group also showed improvements in body composition, with overweight women experiencing a decrease in body fat percentage and overweight men gaining lean body mass, highlighting the effectiveness of combining behavioral challenges with activity tracking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. DiFrancisco-Donoghue, J., Jung, MK., Stangle, A., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Digital Weight Loss Intervention for Parents of Children Being Treated for Obesity: A Prospective Cohort Feasibility Trial. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Harnessing technological solutions for childhood obesity prevention and treatment: a systematic review and meta-analysis of current applications. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Longitudinal accuracy of web-based self-reported weights: results from the Hopkins POWER Trial. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Utility of Fitbit devices among children and adolescents with chronic health conditions: a scoping review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Five-year pediatric use of a digital wearable fitness device: lessons from a pilot case study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The use of a personal digital assistant for dietary self-monitoring does not improve the validity of self-reports of energy intake. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Validity and Reliability of Fitbit Flex for Step Count, Moderate to Vigorous Physical Activity and Activity Energy Expenditure. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of an Activity Tracker and App Intervention to Increase Physical Activity in Whole Families-The Step It Up Family Feasibility Study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. [2022]