M-POWER Feasibility Study
Condition: Weight Reduction; Adherence, Patient
MeSH terms: Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Interventional Behavioral Arm
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment