What side effects are associated with this type of intervention?

Common treatments for obesity that involve mobile tracking technology for physical activity, weight, and nutrition generally have minimal side effects. These interventions primarily focus on lifestyle changes, such as increased physical activity and dietary modifications, which can lead to initial discomfort, muscle soreness, or fatigue as the body adjusts. Additionally, some individuals may experience frustration or anxiety related to tracking their progress. However, these side effects are typically mild and temporary, and the overall benefits of improved health and weight management often outweigh these minor inconveniences.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity, including pharmacological options like liraglutide and extended-release exenatide, which are GLP-1 agonists. These medications have shown efficacy in weight management and glycemic control. Additionally, the combination of phentermine and topiramate has been approved for weight loss, demonstrating significant results in clinical trials. While the H.E.A.L.T.H. Intensive trial focuses on a comprehensive approach using mobile tracking technology for physical activity, weight, and nutrition, these pharmacological treatments can complement such lifestyle interventions to enhance overall outcomes.

What other types of research exist?

Promising alternatives to the H.E.A.L.T.H. Intensive program for obesity patients include: 1) BariFit, a mobile health intervention combining commercial devices and custom text messages to promote physical activity post-bariatric surgery, which has shown feasibility in a pilot study. 2) Mobile applications for weight management, which can serve as low-intensity or adjunct approaches to conventional strategies, though further research is needed to establish their efficacy as stand-alone treatments. 3) Cognitive-behavioral therapy (CBT) interventions, such as the compuLsive Exercise Activity TheraPy (LEAP) for managing compulsive exercise in eating disorders, which may offer insights into behavioral modifications for obesity management.

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Weight-Loss Program with Mobile Tracking for Obesity

N/A

Waitlist Available

Led By Tiffany Stewart, PhD

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years old

Be older than 18 years old

Must not have

Soldiers and family members younger than 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a program called H.E.A.L.T.H. Intensive, which helps Army Soldiers manage their weight and fitness using an app and smart devices. The program tracks their activity and weight, providing personalized advice without needing clinic visits. It aims to help Soldiers meet fitness standards and improve overall well-being.

Who is the study for?

This trial is for Louisiana National Guard members and their families who are over 18, have a BMI ≥ 25, and aren't due to be deployed for a year. Soldiers must exceed weight/fat limits per Army rules. Participants need smartphone access with daily Wi-Fi and should not be pregnant or unable to read.

What is being tested?

The H.E.A.L.T.H. II Intervention combines proven strategies tailored for Army Soldiers with remote monitoring tech like mobile devices that track physical activity, weight, and nutrition—aiming to improve health outcomes related to obesity.

What are the potential side effects?

Since this intervention involves lifestyle changes rather than medication, side effects may include muscle soreness from increased activity or psychological effects such as stress or frustration associated with dietary changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am a soldier or a soldier's family member and I am under 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline Weight at 6 Months and 12 Months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Waitlist Control GroupActive Control1 Intervention

Six month delayed access to the H.E.A.L.T.H. II Intervention - Intensive intervention (wait-list control)

Group II: Active Intervention GroupActive Control1 Intervention

Immediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include lifestyle interventions, pharmacotherapy, and behavioral therapy. Lifestyle interventions, like those in the H.E.A.L.T.H. Intensive trial, use mobile tracking technology to monitor physical activity, weight, and nutrition, promoting a caloric deficit through increased activity and dietary changes. Pharmacotherapy, such as semaglutide, reduces appetite and alters metabolism to decrease caloric intake and increase energy expenditure. Behavioral therapy employs cognitive-behavioral techniques to change eating and activity habits. These treatments are essential for obesity patients as they address the underlying causes of obesity and offer sustainable weight management strategies.

The effectiveness of interventions to treat obesity in survivors of childhood brain tumors: a systematic review protocol.Weight loss in children and adolescents.Screen-time weight-loss intervention targeting children at home (SWITCH): a randomized controlled trial study protocol.