RECRUITING

A Pilot Factorial Trial of an Integrated Lifestyle Intervention

Conditions

Physical Inactivity Overweight and Obesity physical activity obesity weight loss nutrition diet lifestyle intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2

Quick Facts

Study Start:2023-12-04

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06116435

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Danielle M Ostendorf, PhD

CONTACT

303-724-9203

danielle.ostendorf@cuanschutz.edu

Danielle M Ostendorf, PhD

CONTACT

Principal Investigator

Danielle Ostendorf, PhD

PRINCIPAL_INVESTIGATOR

University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Danielle Ostendorf, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04

Study Completion Date2027-03

Study Record Updates

Study Start Date2023-12-04

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

physical activity
obesity
weight loss
nutrition
diet
lifestyle intervention

Additional Relevant MeSH Terms

Physical Inactivity
Overweight and Obesity