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NCT04000880 · OUTCOME

Muscle Mass With Spillage Correction

Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health · Source last updated 2026-07-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Kg
Interval / dispersion
Standard Deviation
Time frame
Pre-intervention (Baseline), 12-month post-intervention

What was measured

Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates kg of muscle mass.

Analysis population: The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.

Groups in this outcome

Project 1: Diet-Exercise

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Project 2: Exercise-Diet

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Project 3: Combined Diet and Exercise

Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Project 1: Diet-Exercise117
Project 2: Exercise-Diet105
Project 3: Combined Diet and Exercise178

Reported measurements

Pre-intervention (Baseline)

Analysis denominator · Participants

GroupSource count
Project 1: Diet-Exercise117
Project 2: Exercise-Diet105
Project 3: Combined Diet and Exercise178
Values in Kg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Project 1: Diet-Exercise28.6813.20Not reportedNot reportedNot reported
Project 2: Exercise-Diet27.468.92Not reportedNot reportedNot reported
Project 3: Combined Diet and Exercise28.089.37Not reportedNot reportedNot reported
12-month post-intervention

Analysis denominator · Participants

GroupSource count
Project 1: Diet-Exercise74
Project 2: Exercise-Diet61
Project 3: Combined Diet and Exercise138
Values in Kg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Project 1: Diet-Exercise27.268.01Not reportedNot reportedNot reported
Project 2: Exercise-Diet27.699.97Not reportedNot reportedNot reported
Project 3: Combined Diet and Exercise28.208.75Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.20
        value
        28.68
      2. group Id
        OG001
        spread
        8.92
        value
        27.46
      3. group Id
        OG002
        spread
        9.37
        value
        28.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        105
      3. group Id
        OG002
        value
        178
      units
      Participants
    title
    Pre-intervention (Baseline)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.01
        value
        27.26
      2. group Id
        OG001
        spread
        9.97
        value
        27.69
      3. group Id
        OG002
        spread
        8.75
        value
        28.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        61
      3. group Id
        OG002
        value
        138
      units
      Participants
    title
    12-month post-intervention
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      105
    3. group Id
      OG002
      value
      178
    units
    Participants
description
Participants are provided with a 30 mg capsule of D3Cr and instructed to take the capsule 3 days prior to their assessment date. The night prior to assessment, they begin fasting and continue fasting until they produce the second urinary void of the day. During this void, a test strip is used. The strip is frozen (0 C or below) until analyzed. The outcome measure indicates kg of muscle mass.
dispersion Type
Standard Deviation
groups
  1. description
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    id
    OG000
    title
    Project 1: Diet-Exercise
  2. description
    Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    id
    OG001
    title
    Project 2: Exercise-Diet
  3. description
    Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).
    id
    OG002
    title
    Project 3: Combined Diet and Exercise
param Type
MEAN
population Description
The number of participants analyzed differ between baseline and 12 months due to withdrawal by participant or loss to follow up.
reporting Status
POSTED
time Frame
Pre-intervention (Baseline), 12-month post-intervention
title
Muscle Mass With Spillage Correction
type
SECONDARY
unit Of Measure
Kg

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Preserved source evidence · Not medical advice