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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the user-friendliness and effectiveness of a mobile app designed to encourage families to be more active and prevent weight gain. Participants are divided into two groups: one uses the Family Fit app, and the other uses only a Fitbit. Families with children aged 9-12 who are not currently very active and live near the University of Florida may qualify. The trial aims to determine if the app helps families exercise more together. As an unphased trial, it offers families a unique opportunity to contribute to research that could enhance family health and activity levels.

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 prior data suggests that this app is safe for family-based physical activity and weight gain prevention?

Research has shown that mobile apps for weight management can improve health for both adults and teens. Apps like the Family Fit app engage the whole family, using a family-based approach. This method helps children and parents manage weight together effectively.

However, some experts caution about possible risks. For instance, apps that track calories or weight might lead to unhealthy habits in kids, such as eating disorders. Therefore, these apps should focus on overall health and activity, not just weight.

In summary, while these apps can be beneficial, they should be used carefully, especially with children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Fit App for preventing weight gain because it offers a unique approach by involving the whole family in health and fitness activities, rather than focusing solely on the individual. Unlike traditional weight management options that might include diet plans or gym memberships, this app leverages family support and motivation, creating a more engaging and sustainable lifestyle change. Additionally, the integration with Fitbit devices provides real-time feedback and personalized insights, helping families track progress and stay motivated together. This holistic and family-oriented strategy could be a game-changer in combating weight gain by fostering a supportive environment.

What evidence suggests that this app is effective for preventing weight gain?

Research has shown that mobile apps can aid in weight management and improve health. A review found that these apps can lead to small weight loss and a lower body mass index (BMI) over 4 to 6 months. About 44% of studies indicated that frequent app use was linked to better weight loss and health outcomes. While some studies did not find significant changes in specific areas, tracking progress with apps remains a helpful way to encourage healthy habits. In this trial, participants will join either the Family Fit Condition or the Fitbit Only Condition. Overall, mobile apps like Family Fit have the potential to help families prevent weight gain. ^{6 7 8 9 10}

Who Is on the Research Team?

Danielle E Jake-Schoffman, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

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Mobile Apps for Weight Management: A Scoping Review Mobile apps for weight loss/management are found to be effective for improving health outcomes in adults and adolescents.

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Effectiveness of Mobile Apps in Promoting Healthy ... This paper aims to conduct a systematic review examining the effectiveness of mobile apps aimed at preventing childhood obesity by promoting health behavior ...

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Effect of a mobile phone application for dietary self ... In our study, the mobile phone application did not significantly improve adherence or ZBMI outcomes. However, self-monitoring remains a well- ...

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The Role of Mobile Apps in Obesity Management: Systematic ... Smartphone apps demonstrate a modest but statistically significant effect on weight loss and BMI reduction over a 4- to 6-month period in individuals with ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887121011250

Efficacy of Interventions That Incorporate Mobile Apps in ... Of the 9 studies, 4 (44%) reported that increased app use or adherence was associated with greater weight loss and health outcomes [29,33,35,39] ...

6. bannerhealth.com bannerhealth.com/healthcareblog/teach-me/are-weight-loss-apps-for-kids-safe

Are Weight Loss Apps Safe for Kids to Use? One of the biggest dangers of weight loss apps is that they can lead to eating disorders. Apps that track calories or weight may make kids ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4978862/

Mobile Apps for Weight Management: A Scoping Review Mobile apps for weight loss/management are found to be effective for improving health outcomes in adults and adolescents.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7819774/

Digital Tools to Support Family-Based Weight Management ... Family-based behavioral therapy is an efficacious approach to deliver weight management counseling to children and their parents.

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06148246/family-fit-iterative-app-development?id=107&page=6&slug=obesity

Family Fit Iterative App Development | Clinical Research ... 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 ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2211335522002479

Review article Effectiveness of mobile health interventions ... We summarized the evidence on the effectiveness of mobile apps for devices used by parents to prevent and treat childhood and adolescent obesity.