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Behavioral Intervention

Integrated Lifestyle Intervention for Obesity

N/A

Recruiting

Led By Danielle Ostendorf, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

- Age 18-65 years

Be older than 18 years old

Must not have

- Cardiac, peripheral vascular, or cerebrovascular disease

- Self-reported diabetes (history of type 1 or type 2 diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how to help people stay active by adding physical activity support to existing lifestyle interventions. #MoveMore #BeActive

Who is the study for?

This trial is for English-speaking men and women aged 18-65 who are overweight or obese with a BMI of 25-45 kg/m2, lead a sedentary lifestyle (exercising less than 150 minutes per week), and have not been in any weight loss or exercise programs recently. They must have access to technology like computers or smartphones with Wi-Fi, and be willing to attend program sessions.

What is being tested?

The study is testing the integration of the Move physical activity support program into an existing lifestyle intervention. Participants will receive various supports such as one-on-one coaching, mental imagery techniques, fitness memberships, group-based classes, and Prevent T2 strategies to encourage healthier living habits.

What are the potential side effects?

Since this trial focuses on lifestyle interventions rather than medication or medical procedures, side effects may include muscle soreness from new physical activities or psychological discomfort due to changes in routine but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

Exclusion Criteria

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

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I have heart, blood vessel, or stroke-related conditions.

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I have been diagnosed with diabetes (type 1 or type 2).

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My blood pressure and heart rate are within normal ranges.

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I need oxygen daily or was hospitalized for severe asthma or COPD in the last year.

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I have not used weight loss drugs in the past 6 months.

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I am not pregnant, have not been pregnant in the last 3 months, and do not plan to become pregnant in the next 5 months.

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I do not regularly use medications that affect my appetite, weight, sleep, or energy.

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I have end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Acceptability of the Move physical activity support program - Qualitative

Feasibility of the Move physical activity support program - Qualitative

Secondary study objectives

Acceptability of the Move physical activity support program components - Quantitative

Feasibility of the Move physical activity support program - Quantitative

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: PreventT2 + Move group-based classes + Move 1:1 SupportExperimental Treatment3 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives.

Group II: PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 SupportExperimental Treatment4 Interventions

Group III: PreventT2 + Move group-based classes + Mental Imagery + Fitness MembershipExperimental Treatment4 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.

Group IV: PreventT2 + Move group-based classes + Mental ImageryExperimental Treatment3 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.

Group V: PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 SupportExperimental Treatment4 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives.

Group VI: PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 SupportExperimental Treatment5 Interventions

Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum, integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. In addition, participants will receive access to online mental guided imagery sessions.

Group VII: PreventT2 + Move group-based classes + Fitness MembershipExperimental Treatment3 Interventions

Group VIII: PreventT2 + Move group-based classesExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mental Imagery

2019

N/A

~150

0 / 9Eligibility criteria met