Trial Outcomes & Findings for Lifestyle Behavior Weight Loss Intervention (NCT NCT04649047)
NCT ID: NCT04649047
Last Updated: 2025-01-31
Results Overview
Self-reported body weight
COMPLETED
NA
15 participants
baseline (T1) and 3 weeks follow up (T2)
2025-01-31
Participant Flow
Participant milestones
| Measure |
Intervention
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Intervention
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Overall Study
Withdrawal by Subject
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3
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Baseline Characteristics
Lifestyle Behavior Weight Loss Intervention
Baseline characteristics by cohort
| Measure |
Intervention
n=15 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Age, Continuous
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32.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=5 Participants
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Race (NIH/OMB)
White
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7 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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15 Participants
n=5 Participants
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Marital Status
Single (never married)
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8 Participants
n=5 Participants
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Marital Status
Married
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5 Participants
n=5 Participants
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Marital Status
Divorced
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2 Participants
n=5 Participants
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Education
High School/GED
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1 Participants
n=5 Participants
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Education
Some College/Technical School (no degree)
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5 Participants
n=5 Participants
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Education
Associate's Degree
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1 Participants
n=5 Participants
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Education
Bachelor's Degree
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4 Participants
n=5 Participants
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Education
Master's Degrees.
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4 Participants
n=5 Participants
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Employment
Full-Time
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4 Participants
n=5 Participants
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Employment
Part-Time
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3 Participants
n=5 Participants
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Employment
Self-Employed
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1 Participants
n=5 Participants
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Employment
Not employed outside of home
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7 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Self-reported body weight
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Body Weight
T1 (baseline)
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194.1 pounds
Standard Deviation 38.04
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Change in Body Weight
T2 (post-intervention)
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191.2 pounds
Standard Deviation 37.70
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Change in Body Weight
T2 vs. T2
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-2.92 pounds
Standard Deviation 4.23
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)kg/m\^2
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Body Mass Index
T1 (baseline)
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32.14 kg/m2
Standard Deviation 5.23
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Body Mass Index
T2 (post-intervention)
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31.58 kg/m2
Standard Deviation 5.20
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Body Mass Index
Change from T1 to T2
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-.56 kg/m2
Standard Deviation .73
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)NCI brief dietary fat intake survey was used to measure dietary fat intake. Participants reported the frequency of each specific food eaten over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.There is no minimum or maximum available for this measure. The following procedures were used to convert an individual's responses to an estimate of that individual's percentage energy from fat: The frequency reported categorically on the questionnaire was converted to the number of times fat was consumed per day as shown below. In general, the midpoint of the frequency range was used. Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784 1. time per day 1.0 2. or more times per day 2.0
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Daily Dietary Fat Intake
T2 (post-intervention)
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31.17 Times fat consumed per day
Standard Deviation 5.06
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Daily Dietary Fat Intake
T2 vs. T1
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-3.42 Times fat consumed per day
Standard Deviation 6.72
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Daily Dietary Fat Intake
T1 (baseline)
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34.59 Times fat consumed per day
Standard Deviation 4.93
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)NCI brief Fruit and Vegetable intake survey was used to measure dietary intake. Participants reported the frequency of each specific food eaten over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fruit and vegetable intake.There is no minimum or maximum available for this measure. The frequency reported categorically on the questionnaire was converted to the number of times fruits/vegetables were consumed per day as shown below. In general, the midpoint of the frequency range was used. Frequency ResponseTimes Per Day Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784 1. time per day 1.0 2. or more times per day 2.0
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Daily Fruit and Vegetable Intake
T2 (post-intervention)
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5.72 Times fruit/vegetable consumed per day
Standard Deviation 3.43
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Daily Fruit and Vegetable Intake
T2 vs. T1
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0.85 Times fruit/vegetable consumed per day
Standard Deviation 1.75
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Daily Fruit and Vegetable Intake
T1 (baseline)
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4.87 Times fruit/vegetable consumed per day
Standard Deviation 3.42
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)NCI brief Added Sugar intake survey was used to measure dietary intake. Participants reported the frequency of each specific food eaten over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.There is no minimum or maximum available for this measure. The frequency reported categorically on the questionnaire was converted to the number of times consumed per day as shown below. In general, the midpoint of the frequency range was used. Frequency ResponseTimes Per Day Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784 1. time per day 1.0 2. or more times per day 2.0
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Frequency of Added Sugar Intake
T2 (post-intervention)
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12.53 Times added sugar consumed per day
Standard Deviation 8.32
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Frequency of Added Sugar Intake
T2 vs. T1
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-8.54 Times added sugar consumed per day
Standard Deviation 17.88
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Frequency of Added Sugar Intake
T1 (baseline)
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21.07 Times added sugar consumed per day
Standard Deviation 14.88
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)The International Physical Activity Questionnaire Short Form (7 items) was be used to measure physical activity. Participants are asked to report frequency (days/week) and duration (hours/ day or minutes/day) of vigorous and moderate physical activities performed in the past 7 days. Participants were asked about 3 specific types of activity: walking, moderate-intensity activity, and vigorous-intensity activity. Participants also reported frequency (days per week) and duration (time per day) for each specific type of activity. To create metabolic equivalent of task (MET, energy expenditure) measures, we multiplied frequency by duration (in hours). We then used the summation times 3.3 MET (walking), 4.0 (moderate physical activity), and 8.0 (vigorous physical activity) to generate physical activity scores in MET units. Higher scores indicated more energy expenditure.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Daily Physical Activity (Metabolic Equivalent Task MET)
T1 (baseline)
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107.0 MET - Minutes per week
Standard Deviation 249.6
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Daily Physical Activity (Metabolic Equivalent Task MET)
T2 (post-interveion)
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171.5 MET - Minutes per week
Standard Deviation 390.0
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Daily Physical Activity (Metabolic Equivalent Task MET)
T2 vs. T1
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64.46 MET - Minutes per week
Standard Deviation 504.1
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for stress management). Participants rated how true each statement was for them related to stress management using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for stress management. Scores can range from 6 - 42. Higher scores indicated higher autonomous motivation.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Autonomous Motivation for Stress Management
T2 (post-intervention)
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40.00 score on a scale
Standard Deviation 2.83
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Change in Autonomous Motivation for Stress Management
T2 vs. T1
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3.50 score on a scale
Standard Deviation 3.97
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Change in Autonomous Motivation for Stress Management
T1 (baseline)
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36.50 score on a scale
Standard Deviation 4.87
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for healthy eating). Participants rated how true each statement was for them related to healthier eating using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for healthy eating. Scores can range from 6 - 42 Higher scores indicated higher autonomous motivation.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Autonomous Motivation for Healthy Eating
T2 vs. T1
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2.67 score on a scale
Standard Deviation 3.58
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Change in Autonomous Motivation for Healthy Eating
T1 (baseline)
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37.58 score on a scale
Standard Deviation 4.01
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Change in Autonomous Motivation for Healthy Eating
T2 (post-intervention)
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40.25 score on a scale
Standard Deviation 3.22
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for physical activity). Participants rated how true each statement was for them related to physical activity using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for physical activity. Scores can range from 6 -42. Higher scores indicated higher autonomous motivation.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Autonomous Motivation for Physical Activity
T1 (baseline)
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36.00 score on a scale
Standard Deviation 5.72
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Change in Autonomous Motivation for Physical Activity
T2 (post-intervention)
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40.50 score on a scale
Standard Deviation 2.71
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Change in Autonomous Motivation for Physical Activity
T2 vs. T1
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4.50 score on a scale
Standard Deviation 5.79
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Self-efficacy. We used surveys to measure self-efficacy. We also used the general self-efficacy scale (10 items) to measure self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 10 - 40. Higher scores meant higher self-efficacy.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in General Self-efficacy
T1 (baseline)
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31.42 score on a scale
Standard Deviation 5.18
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Change in General Self-efficacy
T2 (post-intervention)
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34.83 score on a scale
Standard Deviation 4.24
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Change in General Self-efficacy
T2 vs. T1
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3.42 score on a scale
Standard Deviation 5.88
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Self-efficacy. We used surveys to measure self-efficacy for healthy eating (8 items). Participants rated levels of confidence using a 4-point scale: 1 (not at all confident) to 4 (very confident). We summed responses to the 8 items to create a score for self-efficacy for healthy eating. THigher scores meant higher self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 8 - 32. Higher scores meant higher self-efficacy.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Healthy Eating Self-efficacy
T1 (baseline)
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19.83 score on a scale
Standard Deviation 4.90
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Change in Healthy Eating Self-efficacy
T2 (post-intervention)
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22.25 score on a scale
Standard Deviation 4.88
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Change in Healthy Eating Self-efficacy
T2 vs. T1
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2.42 score on a scale
Standard Deviation 3.96
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Self-efficacy. We used surveys to measure physical activity (10 items). Participants rated levels of confidence using a 4-point scale: 1 (not at all confident) to 4 (very confident). We summed responses to the 10 items to create a score for self-efficacy for physical activity. Higher scores meant higher self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 10 - 40. Higher scores meant higher self-efficacy.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Physical Activity Self-efficacy
T2 vs. T1
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3.83 score on a scale
Standard Deviation 8.39
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Change in Physical Activity Self-efficacy
T1 (baseline)
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25.33 score on a scale
Standard Deviation 7.18
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Change in Physical Activity Self-efficacy
T2 (post-intervention)
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29.17 score on a scale
Standard Deviation 7.41
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)Emotional control. To measure emotional control, we used the Emotion Regulation Questionnaire to assess the emotional regulatory process using reappraisal (6 items) and suppression (4 items). Participants rated the degree of agreement using a 7-point scale: 1 (strongly disagree) to 7 (strongly agree). The suppression items were reverse coded prior to score computation. We summed responses to the 10 items to create a score for emotional control. Scores could range between 10 - 70. Higher scores meant better emotional control.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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Change in Emotion Regulation
T1 (baseline)
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38.50 units on a scale
Standard Deviation 8.34
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Change in Emotion Regulation
T2 (post-intervention)
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42.58 units on a scale
Standard Deviation 10.61
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Change in Emotion Regulation
T2 vs. T1
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4.08 units on a scale
Standard Deviation 5.74
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SECONDARY outcome
Timeframe: baseline (T1) and 3 weeks follow up (T2)We used the Perceived Stress Scale (10 items) to measure stress. Participants rated the frequency of stressful life situations in the past month using a 4-point scale: 1 (never) to 4 (often). We summed responses to the 10 items to create a score for stress. Scores can range from 10-40. Higher scores meant perceived higher levels of stress.
Outcome measures
| Measure |
Intervention
n=12 Participants
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Goal-oriented episodic future thinking: All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
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|---|---|
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Change in Perceived Stress
T1 (baseline)
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18.33 score on a scale
Standard Deviation 6.10
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Change in Perceived Stress
T2 (post-inbtervention)
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14.67 score on a scale
Standard Deviation 6.64
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Change in Perceived Stress
T2 vs. T1
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-3.67 score on a scale
Standard Deviation 7.01
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Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mei-Wei Chang
Ohio State University College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place