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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL161417 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreventT2 + Move group-based classes | Experimental | 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. |
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| PreventT2 + Move group-based classes + Fitness Membership | Experimental | 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. |
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| PreventT2 + Move group-based classes + Mental Imagery | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevent T2 | Behavioral | The PreventT2 curriculum is based on the original 2002 Diabetes Prevention Prevention (DPP) trial and follow-up studies. It promotes modest weight loss (5-7%) and increased physical activity through a lifestyle change program and also reflects new literature on self-efficacy, physical activity, and diet. There are 16 modules that will be delivered over 6 months. Participants will receive a calorie goal and be asked to count calories in order to reduce their caloric intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Move physical activity support program - Qualitative | Acceptability of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives. | 6 months |
| Feasibility of the Move physical activity support program - Qualitative | Feasibility of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Move physical activity support program components - Quantitative | Acceptability of the integrated Move physical activity support program components will be assessed using the Net Promoter Score (NPS) from the participant and provider perspectives. Scores range from -100 to +100, with higher scores indicating a better outcome. | 6 months |
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Inclusion Criteria:
For all types of research participants:
For the patient participants only:
For the provider participants only:
Exclusion Criteria:
For patient participants:
For provider participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle M Ostendorf, PhD | Contact | 303-724-9203 | danielle.ostendorf@cuanschutz.edu | |
| Danielle M Ostendorf, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Ostendorf, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D050177 | Overweight |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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2x2x2 full factorial pilot randomized trial
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Trials participants will know their intervention condition as will the lay coach involved in delivering the intervention. Assessors measuring body composition (DXA), self-reported energy intake, and metabolic parameters will be blinded to participant condition.
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| PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership | Experimental | 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. |
|
| PreventT2 + Move group-based classes + Move 1:1 Support | Experimental | 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. |
|
| PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support | Experimental | 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. |
|
| PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support | Experimental | 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. |
|
| PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support | Experimental | 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. |
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| Move group-based classes | Behavioral | The Move physical activity support program group-based classes are based on Self-Determination Theory and encourage improvements in autonomous motivation for physical activity. These group-based classes are integrated within the Prevent T2 program curricula. |
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| Fitness Membership | Behavioral | Participants will receive 6 months of the Peloton fitness membership. This includes access to livestream and on-demand fitness classes including walking, strength training, yoga, meditation, stretching, etc. |
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| Mental Imagery | Behavioral | Participants will receive access to positive mental guided imagery recordings. Recordings describe a pleasant experience while walking and range from 2-8 minutes in duration. |
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| Move 1:1 Support | Behavioral | Participants will meet individually with their class instructor to receive personalized recommendations on how to incorporate messages from the Move group-based classes into their daily lives. Sessions are based on Self-Determination Theory and will last approximately 45 minutes. |
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| Feasibility of the Move physical activity support program - Quantitative | Feasibility of the Move physical activity support program will be assessed using the Perceived Characteristics of Intervention Scale (PCIS) collected only at the level of the provider. Scores range from 0 to 4, with higher scores indicating a better outcome. | 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |