No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who are overweight and not very active. Participants will join a program to increase physical activity and lifestyle changes over five months.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have access to a computer or smartphone and Wi-Fi.
I speak English.
I have a body mass index (BMI) between 25 and 45.
I do less than 150 minutes of exercise per week.
I am willing to not join other weight loss programs for 5 months.
I have a doctor or can get one before starting the study.
I can give my consent and attend sessions.
You may not be able to join if
I have cardiovascular disease symptoms or conditions.
I am currently pregnant or breastfeeding, or was pregnant in the last 3 months.
I have uncontrolled high blood pressure.
I have self-reported diabetes.
I have a history of severe depression in the last year.
I currently abuse alcohol or drugs.
I have had weight loss surgery in the past year.
I regularly go to a gym or fitness center.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* For all types of research participants:
* Men and Women
* Age 18-65 years
* Have access to a computer and/or smart phone, and Wi-Fi
* Speak English (since all study materials are in English and the intervention will be delivered in a group-class setting with a coach w…
Inclusion Criteria:
* For all types of research participants:
* Men and Women
* Age 18-65 years
* Have access to a computer and/or smart phone, and Wi-Fi
* Speak English (since all study materials are in English and the intervention will be delivered in a group-class setting with a coach who speaks English, we are only able to accommodate English-speakers at this time)
* For the patient participants 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, or physical activity program 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 participants only:
* \>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
Exclusion Criteria:
* For patient participants:
* Considered high risk, based on the American College of Sports Medicine Guidelines for Exercise Testing and Prescription (i.e. have cardiovascular disease symptoms or known cardiovascular disease, 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 16 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 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Episode. Score \> 18 on Beck Depression Inventory (BDI) will require further assessment by the Study Medical Doctor (MD) to determine if it is appropriate for the subject to participate in the study.
* History of other significant psychiatric illnesses (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 Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire on Eating and Weight Patterns-5 (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.
* Currently has access to and uses a fitness membership (defined as having used membership within the past month)
* For provider participants:
* None
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