What side effects are associated with this type of intervention?

Common treatments for obesity include lifestyle interventions such as increased physical activity and dietary changes, as well as pharmacotherapy. Physical activity and dietary changes generally have minimal side effects but can include muscle soreness, fatigue, and potential nutritional deficiencies if not properly managed. Pharmacotherapy for obesity, such as the use of orlistat, can cause gastrointestinal side effects like oily stools, flatulence, and frequent bowel movements. Other medications may have side effects including increased heart rate, insomnia, and potential for addiction. It is important to tailor treatments to individual needs and monitor for adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide and liraglutide. Semaglutide, administered once weekly, has shown significant weight loss in clinical trials, such as the STEP trials, where it was compared with placebo and demonstrated substantial reductions in body weight. Liraglutide, administered daily, has also been approved for weight management and has shown efficacy in reducing body weight. Both drugs are glucagon-like peptide-1 (GLP-1) receptor agonists and are used alongside lifestyle interventions like diet and exercise to enhance weight loss outcomes.

What other types of research exist?

Promising, novel alternatives to community-based physical activity programs for obesity patients in 2024 include: 1) Technology-Based Physical Activity Interventions (TbPAI), which leverage eHealth and digital tools to enhance engagement and outcomes; 2) Structured Exercise Programs (SEP), which provide organized and supervised exercise routines; and 3) Tailored Physical Activity Prescriptions, which customize exercise plans based on individual needs and preferences. These approaches have demonstrated improved physical activity outcomes and positive perceptions among participants.

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Physical Activity for Sedentary Lifestyle

N/A

Waitlist Available

Led By Kathryn Schmitz, PhD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Adults aged 18 and over at the time of enrollment

Either overweight/obese (Body Mass Index (BMI) ≥ 25) or diabetic (hemoglobin A1c ≥ 5.7%)

Must not have

Cardiac exclusion criteria: Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system, history of acute coronary syndromes, uncertain or uncontrolled arrhythmia, uncontrolled hypertension, syncope, acute myocarditis, acute pericarditis, acute endocarditis, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, pulmonary edema, respiratory failure, or acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise

Mental impairment leading to inability to cooperate, provide informed consent, or follow study instructions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months vs. baseline

Summary

This trial aims to help inactive adults in rural Pennsylvania become more physically active through a telephone-based coaching program called the MoveLine. The program provides personalized advice and support over the phone. Increased physical activity can help reduce the risk of cancer and improve overall health.

Who is the study for?

This trial is for adults over 18 living in rural Pennsylvania who are overweight, obese, or have Type 2 diabetes and do less than 90 minutes of exercise a week. They must be able to walk, speak English, understand the study details, and not be pregnant or have severe health issues that could interfere with their participation.

What is being tested?

The PA Moves Trial aims to increase physical activity among physically inactive rural residents. Participants will start a physical activity program at different times to compare how starting at various points affects their health outcomes.

What are the potential side effects?

Since this trial involves increasing physical activity, potential side effects may include muscle soreness, fatigue, and an increased risk of injury if activities aren't performed correctly or without proper guidance.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am either overweight or have diabetes.

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I can walk a quarter mile by myself.

Exclusion Criteria

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

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I do not have serious heart conditions or recent major heart or lung issues.

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I am able to understand and follow the study's requirements.

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I have a severe bone or joint condition.

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I use devices like a cane or walker to help me walk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months vs. baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months vs. baseline

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

Treatment Details

Study Objectives

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

Primary study objectives

Objective accelerometry

Physical Activity Questionnaire

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Physical Activity interventionActive Control1 Intervention

Five physical activity coaching calls with MoveLine and weekly physical activity. Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

Group II: Delayed interventionPlacebo Group1 Intervention

Objective tracking of activity with an accelerometer will occur at baseline, after 12 months, and after 24 months.

0 / 7Eligibility 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 behavioral interventions, pharmacotherapy, and lifestyle changes. Behavioral interventions, like community-based physical activity programs, focus on increasing physical activity and promoting healthier eating habits through education and support. Pharmacotherapy involves medications that reduce appetite or increase satiety, helping to lower caloric intake. Lifestyle changes, such as improved diet and regular exercise, create a caloric deficit leading to weight loss. These treatments are essential for obesity patients as they tackle the underlying causes of obesity and offer sustainable methods for long-term weight management.