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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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The objective of this study is to design and refine an activity support program for overweight or obese adults called Move. The primary outcomes are feasibility and acceptability of the Move physical activity support program.
The purpose of this study is to design and refine a physical activity support program called Move, designed for adults with overweight or obesity. Participants will receive a 12-week, virtual physical activity support program called Move. Move includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) mental guided imagery sessions. Participants will be asked to build their physical activity levels up to 150 minutes/week. The primary outcome is to evaluate the program's acceptability and feasibility from both the participant and the provider perspectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Move physical activity support program | Experimental | Participants receive the Move physical activity support program over 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Move physical activity support program | Behavioral | The Move program includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) weekly mental guided imagery sessions. Participants will be asked to build up their physical activity levels up to 150 minutes/week. They will receive an online fitness center membership during this entire 12-week program. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Scores from the Acceptability of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability. | 12 weeks |
| Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Scores from the Feasibility of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability. | 12 weeks |
| Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Acceptability of the Move physical activity support program will be assessed using the Net Promoter Score (NPS) from the participant and provider perspectives. The score is calculated as a composite score from responders. Each responder rates the program between 0 and 10. Each responder is categorized as promotors (scores 9-10), passives (scores 7-8), or detractors (scores 0-6). The NPS is then calculated by the [% of promoters (scores 9 or 10) minus % detractors (scores 6 or lower)] multiplied by 100. Possible scores ranges from -100 to +100. Scores >0 indicate the component is acceptable. Negative scores indicate that a higher percentage of respondents were classified as detractors (scores 6 or lower) compared to promoters (scores 9 or 10). Only one score is calculated per support program type. There is no measure of central tendency for this outcome. See https://www.netpromoter.com/know/ for more information in how this score is calculated. | 12 weeks |
| 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. | 12 weeks |
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Inclusion Criteria:
For both participant partners and the provider partner:
For the participant partners only:
For the provider partners only:
Exclusion Criteria:
For participant partners:
For provider partners:
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| 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 | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Community Members | Participants receive the Move physical activity support program over 12 weeks. Move physical activity support program: The Move program includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) weekly mental guided imagery sessions. Participants will be asked to build up their physical activity levels up to 150 minutes/week. They will receive an online fitness center membership during this entire 12-week program. |
| FG001 | Coaches | Coach delivered the Move physical activity support program |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Results are only reported at the level of the community member (n=9) and not at the level of the coach (n=1) to maintain confidentiality for the coach.
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| ID | Title | Description |
|---|---|---|
| BG000 | Community Members | Participants receive the Move physical activity support program over 12 weeks. Move physical activity support program: The Move program includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) weekly mental guided imagery sessions. Participants will be asked to build up their physical activity levels up to 150 minutes/week. They will receive an online fitness center membership during this entire 12-week program. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Scores from the Acceptability of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability. | All participants who started the intervention (n=9 community members, n=1 coach) were included in the analysis. Since there is only 1 coach, 95% CIs are not reported at the coach level. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
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12 weeks
Adverse events were recorded as they occurred throughout the 12-week intervention period. Adverse event data were not collected from coaches. Adverse event data were only collected at the community member level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Community Members | Participants receive the Move physical activity support program over 12 weeks. Move physical activity support program: The Move program includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) weekly mental guided imagery sessions. Participants will be asked to build up their physical activity levels up to 150 minutes/week. They will receive an online fitness center membership during this entire 12-week program. |
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As this was a pilot feasibility study, only a small number of participants were included and analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle M. Ostendorf | University of Colorado | 3037249203 | danielle.ostendorf@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2023 | Aug 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| OG001 | Coach | A coach delivered the Move physical activity support program. |
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| Primary | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Scores from the Feasibility of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability. | All participants who started the intervention (n=9 community members, n=1 coach) were included in the analysis. Since there is only 1 coach, 95% CIs are not reported for the coach level data. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
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|
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| Primary | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Acceptability of the Move physical activity support program will be assessed using the Net Promoter Score (NPS) from the participant and provider perspectives. The score is calculated as a composite score from responders. Each responder rates the program between 0 and 10. Each responder is categorized as promotors (scores 9-10), passives (scores 7-8), or detractors (scores 0-6). The NPS is then calculated by the [% of promoters (scores 9 or 10) minus % detractors (scores 6 or lower)] multiplied by 100. Possible scores ranges from -100 to +100. Scores >0 indicate the component is acceptable. Negative scores indicate that a higher percentage of respondents were classified as detractors (scores 6 or lower) compared to promoters (scores 9 or 10). Only one score is calculated per support program type. There is no measure of central tendency for this outcome. See https://www.netpromoter.com/know/ for more information in how this score is calculated. | All participants who started the intervention (n=9 community members, n=1 coach) were included in the analysis. | Posted | Number | units on a scale | 12 weeks |
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| Primary | 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. | The coach who delivered the Move program completed this questionnaire at 12 weeks and was included in the analysis. Community members were not asked to complete this survey. The survey was only collected at the coach level. | Posted | Number | score on a scale | 12 weeks |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Guided imagery sessions |
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| Online fitness membership |
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| Guided imagery sessions |
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| Online fitness membership |
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