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

NCT05865392 | Completed Results

• 2 other identifiers: 22-2183K01HL161417
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Physical Inactivity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Move physical activity support program

EXPERIMENTAL

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

Behavioral: Move physical activity support program

Interventions

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.

Move physical activity support program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• For the provider partners only:
• \>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

As this was a pilot feasibility study, only a small number of participants were included and analyzed.

Results Point of Contact

• Title: Dr. Danielle M. Ostendorf
• Organization: University of Colorado

danielle.ostendorf@cuanschutz.edu

3037249203

Study Officials

• Danielle Ostendorf, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 18, 2023
• Study Start: February 16, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)