M-POWER Feasibility Study

NCT05921565 | Completed

• 1 other identifier: STU00207968
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a new weight loss intervention designed for cancer survivors who have heart disease or cardiometabolic conditions. The investigators want to determine whether this study is feasible and acceptable to participants. The investigators also want to learn more about how cancer survivors take their medications.

Conditions

Weight Reduction; Adherence, Patient

Outcome Measures

Primary Outcomes (1)

• Primary Outcome - Weight - Aria Scale

  Weight will be measured in the lab at baseline and then the change in weight at the follow-up. Baseline measurements occur one week before the study and follow up measurements occur at week 8 of the study. Measurements will be taken without shoes, wearing light clothing on a calibrated beam balance scale called the Aria Scale. For melanoma patients only, skin self-examination frequency will also be assessed.

  Baseline (week one) & Follow Up (week 8)

Secondary Outcomes (1)

• Additional Physiologic Outcomes

  Baseline (week one) & Follow Up (week 8)

Study Arms (1)

Single Behavioral Arm

EXPERIMENTAL

Everyone in the study will receive the same type of treatment. They will all receive a treatment period that will last for 8 weeks. All participants will be given a 3% total weight loss goal, a daily calorie goal ranging from 1200-2000 kcal/day based on body weight, and a daily fat goal based on 25% of total daily calories from fat, and an option to stop their food/energy intake at 6pm every day without altering any other meal times. .Participants will also be asked to use two meal replacements per day. Participants will also be given a physical activity goal of 100 minutes per week.

Behavioral: Interventional Behavioral Arm

Interventions

Interventional Behavioral Arm BEHAVIORAL

All participants will receive a weight loss intervention that includes 8 coaching sessions guided by a workbook they will at their baseline visit. During these sessions, they will meet with a health coach individually for up to 10-15 minutes via telephone or video conference to learn and discuss weight loss strategies. Health coaches will provide feedback and instruction (by phone or email) based on progress and challenges encountered during the intervention. Participants will receive a weight management app custom-built for the research study. The app will display participants' dietary intake, physical activity, and weight data and goals on the smartphone, and participants will use the app to log dietary intake, physical activity, and weight daily.

Single Behavioral Arm

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer survivors between ages 18 and 84
• BMI between ≥25 - 45 kg/m2
• \<350 lbs.; weight stable (no loss or gain \>15 lbs. for the past 3 months)
• Own a smartphone (Android or iOS) and web camera, be willing to install the M-POWER App
• Will voluntarily provide informed consent
• Reside in the Chicagoland area for the duration of their participation (i.e., 3 months)
• Maintain at-home internet and WiFi service for the entirety of their participation
• Cancer survivors with a history of breast cancer (up to stage IIIa), melanoma (up to stage IIb), prostate cancer (up to stage IIIb) or colorectal cancer (up to stage IIIa).

You may not qualify if:

• Inability to speak and read English
• Unstable medical conditions
• Uncontrolled hypertension
• Diabetes - uncontrolled or treated with insulin
• Uncontrolled hypothyroidism
• Unstable angina pectoris
• Transient ischemic attack
• Cancer undergoing active treatment (\< 3 months since most recent surgery, chemotherapy, or radiation treatment for cancer)
• Cerebrovascular accident or myocardial infarction within the past six months, Crohn's disease)
• Pregnancy, lactation or intended pregnancy
• Active suicidal ideation
• Anorexia
• Bulimia
• Binge eating disorder
• Requiring an assistive device for mobility, or those with any current condition that may limit or prevent participation in moderate physical activity

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Weight Loss; Patient Compliance

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventive Medicine

Model Details: To explore individual differences in responses to the weight loss intervention as well as mechanisms underlying its effects, additional survey measures will be administered. These measures will include: demographics, other health information, motivations for losing weight (TSR-Q), personality (BFI-10), chronic stress (Life Events Inventory) perceived stress (PSS-10), stress in past week, the positive and negative affect scale, PROMIS scale of cognitive function PROMIS scales of physical function, PROMIS scales of mental health, PROMIS scales of social health, fear of cancer recurrence, and self-efficacy for diet and exercise. PROMIS items will be assessed using computerized adaptive testing versions with items drawn from banks specific to the individual constructs assessed.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 27, 2023
• Study Start: March 11, 2019
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

US (1)