Overweight and Obesity, Physical Inactivity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMove 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
For both participant partners and the provider partner: * Have access to a computer and/or smart phone, and Wi-Fi * Speak English For the participant partners only: * Body Mass Index 25-45 kg/m2 * Insufficiently active (defined as \<150 min/week of voluntary exercise at moderate intensity over the past 3 months) * Willing not to enroll in any other formal weight loss, physical activity program, or fitness center membership over the next 5 months. * Have a primary care physician (or has access to a healthcare professional and/or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions. * Capable and willing to give informed consent, understand
Exclusion criteria
, attend the Move+ program sessions, and complete outcome measures. For the provider partners only: * \>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | 12 weeks | Scores from the Acceptability of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability. |
| Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | 12 weeks | Scores from the Feasibility of Intervention Measure (AIM) range from 1 to 5, with higher scores indicating higher acceptability. |
| Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | 12 weeks | 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. |
| Feasibility of the Move Physical Activity Support Program - Quantitative | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Didn't meet inclusion criteria | 4 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Community Members |
|---|---|
| Age, Continuous | 45.3 years |
| Body Mass Index | 33.3 kg/m2 STANDARD_DEVIATION 4.4 |
| Diastolic Blood Pressure | 78.5 mmHg STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 1 Participants |
| Systolic Blood Pressure | 121.5 mmHg STANDARD_DEVIATION 12.4 |
| Weight | 89.9 kg STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Community Members | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Group-based classes | 4.14 score on a scale |
| Community Members | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | 1:1 support sessions | 4.28 score on a scale |
| Community Members | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Guided imagery sessions | 3.25 score on a scale |
| Community Members | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Online fitness membership | 4.44 score on a scale |
| Coach | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Online fitness membership | 5 score on a scale |
| Coach | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Group-based classes | 5 score on a scale |
| Coach | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | Guided imagery sessions | 4 score on a scale |
| Coach | Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) | 1:1 support sessions | 5 score on a scale |
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.
Time frame: 12 weeks
Population: All participants who started the intervention (n=9 community members, n=1 coach) were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Community Members | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Group-based Class Component | 11 units on a scale |
| Community Members | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | 1:1 support sessions | 22 units on a scale |
| Community Members | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Guided imagery sessions | -22 units on a scale |
| Community Members | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Online fitness membership | 56 units on a scale |
| Coach | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Online fitness membership | 0 units on a scale |
| Coach | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Group-based Class Component | 100 units on a scale |
| Coach | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | Guided imagery sessions | 0 units on a scale |
| Coach | Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) | 1:1 support sessions | 100 units on a scale |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Community Members | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Guided imagery sessions | 3.81 score on a scale |
| Community Members | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Group-based classes | 4.00 score on a scale |
| Community Members | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Online fitness membership | 4.03 score on a scale |
| Community Members | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | 1:1 support sessions | 4.08 score on a scale |
| Coach | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Online fitness membership | 1.25 score on a scale |
| Coach | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | 1:1 support sessions | 4.25 score on a scale |
| Coach | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Guided imagery sessions | 4 score on a scale |
| Coach | Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) | Group-based classes | 5 score on a scale |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Community Members | Feasibility of the Move Physical Activity Support Program - Quantitative | 3.5 score on a scale |