N/A
N=18
A 12-week Field Trial of the Move Physical Activity Support Program
Overweight and Obesity · Physical Inactivity
Bottom Line
View on ClinicalTrials.gov: NCT05865392 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) — 4.14; 5; 4.28; 5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Move physical activity support program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) |
4.14; 5; 4.28; 5; 3.25; 4 | — |
| PRIMARY Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM) |
4.00; 5; 4.08; 4.25; 3.81; 4 | — |
| PRIMARY Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS) |
11; 100; 22; 100; -22; 0 | — |
| PRIMARY Feasibility of the Move Physical Activity Support Program - Quantitative |
3.5 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT05865392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.