Overweight and ObesityNCT05865392

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

A study testing Move physical activity support program in people with Overweight and Obesity and Physical Inactivity, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity, Physical Inactivity
What is being tested?: Move physical activity support program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 16 Feb 2023to 30 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Show all 11Show fewer

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.

Who cannot join

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:

Show all 23Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Designing With Dissemination in Mind: Development of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy; Aim 1, Phase 2

Read the 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.

Conditions: Overweight and Obesity, Physical Inactivity
Being tested: Move physical activity support program
Medical subject headings: Overweight, Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Move physical activity support programBehavioural
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.

Study groups in NCT05865392
Study group	Role	What they receive
Move physical activity support program	Experimental	Participants receive the Move physical activity support program over 12 weeks. Receives: Behavioral: Move physical activity support program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202330 Aug 2023

First posted18 May 2023
Study start16 Feb 2023
Primary completion30 Aug 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05865392
Sponsor's protocol ID: 22-2183
Other IDs: K01HL161417
Status last verified: Jun 2025
First submitted: 24 Apr 2023
Last updated: 10 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overweight and Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Designing With Dissemination in Mind: Development of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy; Aim 1, Phase 2
ClinicalTrials.gov ID: NCT05865392
Acronym / sponsor ID: 22-2183
Conditions: Overweight and Obesity, Physical Inactivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 16 Feb 2023 (actual)
Primary completion: 30 Aug 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 18 May 2023 (actual)
Results: Posted 10 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Move physical activity support program	Experimental	Behavioral: Move physical activity support programParticipants receive the Move physical activity support program over 12 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Have access to a computer and/or smart phone, and Wi-Fi
Speak English
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.

Key exclusion criteria (23 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Move physical activity support programThe 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.	Behavioural	Move physical activity support program

Primary outcome

Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 10 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Community Members	17	9
Coaches	1	1

Primary outcome: Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM)

Time frame: 12 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Community Members n = 9	Coach n = 1
Group-based classes	4.14 (3.66 to 4.62)	5
1:1 support sessions	4.28 (3.70 to 4.86)	5
Guided imagery sessions	3.25 (2.22 to 4.28)	4
Online fitness membership	4.44 (3.61 to 5.28)	5

Population analysed: 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.

Primary outcome: Feasibility of Move Program Components, Measured With the Feasibility of Intervention Measure (FIM)

Time frame: 12 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Community Member n = 9	Coach n = 1
Group-based classes	4.00 (3.60 to 4.40)	5
1:1 support sessions	4.08 (3.61 to 4.55)	4.25
Guided imagery sessions	3.81 (2.82 to 4.79)	4
Online fitness membership	4.03 (2.73 to 5.32)	1.25

Primary outcome: Acceptability of the Move Physical Activity Support Program, Measured With the Net Promoter Score (NPS)

Time frame: 12 weeks. Number. Unit: units on a scale

Measure	Community Member n = 9	Coach n = 1
Group-based Class Component	11	100
1:1 support sessions	22	100
Guided imagery sessions	-22	0
Online fitness membership	56	0

Population analysed: All participants who started the intervention (n=9 community members, n=1 coach) were included in the analysis.

Primary outcome: Feasibility of the Move Physical Activity Support Program - Quantitative

Time frame: 12 weeks. Number. Unit: score on a scale

Measure	Coach n = 1
Value	3.5

Population analysed: 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.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Community Members	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): As this was a pilot feasibility study, only a small number of participants were included and analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Danielle Ostendorf, PhD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Move physical activity support program in people with Overweight and Obesity and Physical Inactivity, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Move Program Components, Measured With the Acceptability of Intervention Measure (AIM) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05865392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.