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A 12-week Field Trial of the Move Physical Activity Support Program

Primary Purpose

Overweight and Obesity, Physical Inactivity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Move physical activity support program
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. Exclusion Criteria: For participant partners: Considered high risk, based on the American College of Sports Medicine Guidelines for Exercise Testing and Prescription60 (i.e. have CVD symptoms or known CVD, diabetes, or end-stage renal disease). Females who are currently pregnant or lactating, were pregnant within the past 3 months, or planning to become pregnant in the next 5 months will also be excluded Self-reported cardiovascular disease: Cardiac, peripheral vascular, or cerebrovascular disease Self-reported symptoms suggestive of cardiovascular disease: pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from cardiac ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication. Self-reported end-stage renal disease Self-reported diabetes (history of type 1 or type 2 diabetes) Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate at the screening visit after 5 minutes of rest in a seated position. Self-reported pulmonary disease requiring chronic oxygen supplementation; severe asthma or chronic obstructive pulmonary disease requiring hospitalization in past year. Plans to relocate in the next 4 months Currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on BDI will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the exercise intervention. History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the EATS-26 or pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. Current alcohol or substance abuse Nicotine use (current or past 6 months) Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) Regular use of obesity pharmacotherapeutic agents within the last 6 months. Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening. For provider partners: None

Sites / Locations

  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Move physical activity support program

Arm Description

Participants receive the Move physical activity support program over 12 weeks.

Outcomes

Primary Outcome Measures

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 qualitative interviews from the participant and provider perspectives.
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 qualitative interviews from the participant and provider perspectives.

Secondary Outcome Measures

Acceptability of the Move physical activity support program - Quantitative
Acceptability of the Move physical activity support program 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.
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.

Full Information

First Posted
April 24, 2023
Last Updated
May 9, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05865392
Brief Title
A 12-week Field Trial of the Move Physical Activity Support Program
Official Title
Designing With Dissemination in Mind: Development of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy; Aim 1, Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Physical Inactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Move physical activity support program
Arm Type
Experimental
Arm Description
Participants receive the Move physical activity support program over 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Move physical activity support program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the Move physical activity support program - Qualitative
Description
Acceptability of the Move physical activity support program will be assessed with results of the semi-structured qualitative interviews from the participant and provider perspectives.
Time Frame
12 Weeks
Title
Feasibility of the Move physical activity support program - Qualitative
Description
Feasibility of the Move physical activity support program will be assessed with results of the semi-structured qualitative interviews from the participant and provider perspectives.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Acceptability of the Move physical activity support program - Quantitative
Description
Acceptability of the Move physical activity support program 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.
Time Frame
12 weeks
Title
Feasibility of the Move physical activity support program - Quantitative
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Exclusion Criteria: For participant partners: Considered high risk, based on the American College of Sports Medicine Guidelines for Exercise Testing and Prescription60 (i.e. have CVD symptoms or known CVD, diabetes, or end-stage renal disease). Females who are currently pregnant or lactating, were pregnant within the past 3 months, or planning to become pregnant in the next 5 months will also be excluded Self-reported cardiovascular disease: Cardiac, peripheral vascular, or cerebrovascular disease Self-reported symptoms suggestive of cardiovascular disease: pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from cardiac ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication. Self-reported end-stage renal disease Self-reported diabetes (history of type 1 or type 2 diabetes) Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate at the screening visit after 5 minutes of rest in a seated position. Self-reported pulmonary disease requiring chronic oxygen supplementation; severe asthma or chronic obstructive pulmonary disease requiring hospitalization in past year. Plans to relocate in the next 4 months Currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on BDI will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the exercise intervention. History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the EATS-26 or pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. Current alcohol or substance abuse Nicotine use (current or past 6 months) Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) Regular use of obesity pharmacotherapeutic agents within the last 6 months. Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening. For provider partners: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Ostendorf, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A 12-week Field Trial of the Move Physical Activity Support Program

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