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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05865392
• Other study ID #: 22-2183
• Secondary ID: K01HL161417
• Status: Completed
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Physical Inactivity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Weeks
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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