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M-POWER Feasibility Study (M-POWER)

Primary Purpose

Weight Reduction, Adherence, Patient

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interventional Behavioral Arm
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Reduction

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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 Upcoming reconstructive surgery scheduled to take place during the study period and/or < 3months have elapsed since reconstructive surgery Substance abuse or dependence besides nicotine dependence Active treatment of the primary cancer Individuals that have ever had bariatric (or LapBand surgery)

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Behavioral Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Additional Physiologic Outcomes
Height will also be measured using a stadiometer.

Full Information

First Posted
May 15, 2023
Last Updated
June 30, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05921565
Brief Title
M-POWER Feasibility Study
Acronym
M-POWER
Official Title
Mobile - PrOmoting Wellness After cancER Study: M-POWER Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this study is to test a new weight loss intervention designed for cancer survivors. The investigators want to determine whether this approach to weight loss is feasible and acceptable to cancer survivors. All participants in the study will receive free behavioral telephone-based weight loss management in the Department of Preventive Medicine at Northwestern University. Participants must be willing and able to use their smartphone with Bluetooth and their WiFi to download Apps, set up a Fitbit account and a Google account if not already set up. Participants will use their smartphone to record food intake & physical activity over an 8 week weight loss program. This program includes recruitment of a "Buddy" that the participant will choose to support you during the 8 week study. All participants will be asked to download a study application to use to record dietary intake each day during a "Run-In Week.". Eligible participants will then receive an 8-week weight loss program, including individual weekly sessions with health coaches. The investigators will also ask participants to complete both a baseline and follow-up session with study staff. If permitted by current university policies, these sessions will be held at the offices on Northwestern University's Chicago campus. Otherwise, these sessions will be conducted remotely via Zoom videoconference. If this is the case, as a privacy safeguard, the waiting room feature will be applied so that study staff can control who is admitted into the meeting. We expect that the participants will be in this research study for about 10 weeks. The primary risk of participation is muscle soreness or injury from increased physical activity, as well as feelings of hunger from making changes to diet. The main benefit is that a participant may experience positive changes to their health and mood based on the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Reduction, Adherence, Patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Behavioral Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interventional Behavioral Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome - Weight - Aria Scale
Description
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.
Time Frame
Baseline (week one) & Follow Up (week 8)
Secondary Outcome Measure Information:
Title
Additional Physiologic Outcomes
Description
Height will also be measured using a stadiometer.
Time Frame
Baseline (week one) & Follow Up (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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 Upcoming reconstructive surgery scheduled to take place during the study period and/or < 3months have elapsed since reconstructive surgery Substance abuse or dependence besides nicotine dependence Active treatment of the primary cancer Individuals that have ever had bariatric (or LapBand surgery)
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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M-POWER Feasibility Study

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