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Behavioral Intervention

Integrated Lifestyle Intervention for Obesity

N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 65 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the Move physical activity support program - Qualitative
Feasibility of the Move physical activity support program - Qualitative
Secondary outcome measures
Acceptability of the Move physical activity support program components - Quantitative
Feasibility of the Move physical activity support program - Quantitative

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
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. 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 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
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.
Group VIII: PreventT2 + Move group-based classesExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mental Imagery
2019
N/A
~150

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,462 Total Patients Enrolled
2 Trials studying Sedentary Lifestyle
373 Patients Enrolled for Sedentary Lifestyle
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,060 Total Patients Enrolled
5 Trials studying Sedentary Lifestyle
2,473 Patients Enrolled for Sedentary Lifestyle
Danielle Ostendorf, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any possibility for me to be involved in this medical experiment?

"Prospective participants should have an inactive lifestyle and be within the prescribed age range of 18 to 65. Altogether, 64 patients need to be recruited for this clinical trial."

Answered by AI

Are senior citizens being considered for this medical experiment?

"According to the specifications, only those aged 18-65 are eligible for this clinical trial. In contrast, there are 76 trials targeting patients younger than 18 and 302 that focus on adults older than 65 years old."

Answered by AI

Does this research endeavor accept current applications?

"According to the information published on clinicaltrials.gov, this particular medical trial is not currently enrolling participants as of October 30th 2023. The original post date of November 1st 2023 has since been updated however 467 other studies are still actively searching for new patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
2023. "A Pilot Factorial Trial of an Integrated Lifestyle Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06116435.
All > Diet
~43 spots leftby Oct 2026
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