Clinical trial NCT06116435: A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Official title: Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Overweight and Obesity
Keywords: physical activity
obesity
weight loss
nutrition
diet
lifestyle intervention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-11-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2 full factorial pilot randomized trial
Primary purpose: TREATMENT

Brief summary: 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.


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 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

Primary outcomes:
measure: Acceptability of the Move physical activity support program - Qualitative
timeFrame: 6 months
measure: Feasibility of the Move physical activity support program - Qualitative
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of the Move physical activity support program components - Quantitative
timeFrame: 6 months
measure: Feasibility of the Move physical activity support program - Quantitative
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Danielle Ostendorf, PhD
role: PRINCIPAL_INVESTIGATOR
References: