Obesity, Weight Loss
Conditions
Keywords
low-income women, weight loss
Brief summary
This lifestyle behavior intervention aims to weight loss in low-income overweight or obese mothers of young children through promotion of stress management, healthy eating, and physical activity. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions.
Detailed description
Previous research in lifestyle behavior weight loss intervention has 3 limitations. (1) Low-income overweight or obese mothers of young children have been significantly underrepresented. (2) Prior lifestyle interventions in overweight or obese mothers have suffered from threats to internal validity and have not specifically addressed motivation, emotion, and cognition (especially executive function), all of which are critical for promoting and maintaining healthy lifestyle behaviors and health outcomes. (3) There has been little evidence that any of the potentially efficacious strategies researched previously were even possible under real-world conditions. The proposed small pilot study builds on strength and effectively addresses limitations of prior research. The ultimate goal of the proposed study is to create a more feasible and scalable intervention that can be easily implemented and sustained in real-world settings. This self-directed, web-based goal-oriented episodic future thinking intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (impulsivity). the will lead to weight loss and decrease risk of chronic conditions associated with obesity, for example, hypertension, type 2 diabetes, and cancer. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions. We will enroll 30 low-income overweight or obese mothers of young children with diverse racial and ethnic backgrounds. All participants will be assessed at baseline (T1) and immediately after the three-week intervention (T2). Specific aims are to to (1) assess intervention fidelity (dose, delivery, receipt) and acceptability by the study participants, (2) investigate potential intervention impact on the primary (body weight) and secondary outcomes (waist circumference), (3) explore potential intervention impact on lifestyle behaviors (diet and physical activity), (4) explore potential intervention impact on motivation (autonomous motivation, self-efficacy, social support), emotion (emotion control, stress), and cognition (impulsivity), and (5) assess cost of different recruitment approaches.
Interventions
BEHAVIORALGoal-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
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index of 25.0-39.9 kg/m2 (calculated using height and weight) * Current enrollment in government assistant programs (for example, WIC, food stamp (SNAP), or Madicaid) * 6 weeks - 3.5 years postpartum * 18-45 years old * Fluency in speaking, reading, and writing English * Ownership of a smart phone with unlimited text messages and internet access * Committed to a three-week intervention study
Exclusion criteria
* Current pregnancy or lactation * Plan to become pregnant during the trial * Type 1 or 2 diabetes * Untreated thyroid disease * Drug or alcohol abuse or dependence within last six months * Major psychiatric disorder (e.g., schizophrenia, bipolar) * History of bulimia or anorexia * Current taking of appetite suppressant or (antipsychotic) medications known to affect body weight * Current participation in a weight control or drug study * Current or planned participation in a commercial weight loss program * Previous weight loss surgery * Contraindications to physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | baseline (T1) and 3 weeks follow up (T2) | Self-reported body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Dietary Fat Intake | 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 |
| Daily Fruit and Vegetable Intake | 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 |
| Frequency of Added Sugar Intake | 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 |
| Daily Physical Activity (Metabolic Equivalent Task MET) | 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. |
| Change in Autonomous Motivation for Stress Management | 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. |
| Change in Autonomous Motivation for Healthy Eating | 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. |
| Body Mass Index | baseline (T1) and 3 weeks follow up (T2) | kg/m\^2 |
| Change in General Self-efficacy | 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. |
| Change in Healthy Eating Self-efficacy | 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. |
| Change in Physical Activity Self-efficacy | 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. |
| Change in Emotion Regulation | 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. |
| Change in Perceived Stress | 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. |
| Change in Autonomous Motivation for Physical Activity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 6.9 |
| Education Associate's Degree | 1 Participants |
| Education Bachelor's Degree | 4 Participants |
| Education High School/GED | 1 Participants |
| Education Master's Degrees. | 4 Participants |
| Education Some College/Technical School (no degree) | 5 Participants |
| Employment Full-Time | 4 Participants |
| Employment Not employed outside of home | 7 Participants |
| Employment Part-Time | 3 Participants |
| Employment Self-Employed | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Marital Status Divorced | 2 Participants |
| Marital Status Married | 5 Participants |
| Marital Status Single (never married) | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Change in Body Weight
Self-reported body weight
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Body Weight | T1 (baseline) | 194.1 pounds | Standard Deviation 38.04 |
| Intervention | Change in Body Weight | T2 (post-intervention) | 191.2 pounds | Standard Deviation 37.7 |
| Intervention | Change in Body Weight | T2 vs. T2 | -2.92 pounds | Standard Deviation 4.23 |
p-value: 0.03695% CI: [-5.6, -0.23]t-test, 2 sided
Secondary
Body Mass Index
kg/m\^2
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Body Mass Index | T1 (baseline) | 32.14 kg/m2 | Standard Deviation 5.23 |
| Intervention | Body Mass Index | Change from T1 to T2 | -.56 kg/m2 | Standard Deviation 0.73 |
| Intervention | Body Mass Index | T2 (post-intervention) | 31.58 kg/m2 | Standard Deviation 5.2 |
p-value: -0.7795% CI: [-1.02, -0.1]t-test, 2 sided
Secondary
Change in Autonomous Motivation for Healthy Eating
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Autonomous Motivation for Healthy Eating | T1 (baseline) | 37.58 score on a scale | Standard Deviation 4.01 |
| Intervention | Change in Autonomous Motivation for Healthy Eating | T2 (post-intervention) | 40.25 score on a scale | Standard Deviation 3.22 |
| Intervention | Change in Autonomous Motivation for Healthy Eating | T2 vs. T1 | 2.67 score on a scale | Standard Deviation 3.58 |
p-value: 0.6195% CI: [-0.1, 4.94]t-test, 2 sided
Secondary
Change in Autonomous Motivation for Physical Activity
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Autonomous Motivation for Physical Activity | T1 (baseline) | 36.00 score on a scale | Standard Deviation 5.72 |
| Intervention | Change in Autonomous Motivation for Physical Activity | T2 (post-intervention) | 40.50 score on a scale | Standard Deviation 2.71 |
| Intervention | Change in Autonomous Motivation for Physical Activity | T2 vs. T1 | 4.50 score on a scale | Standard Deviation 5.79 |
p-value: 0.7895% CI: [0.82, 8.18]t-test, 2 sided
Secondary
Change in Autonomous Motivation for Stress Management
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Autonomous Motivation for Stress Management | T1 (baseline) | 36.50 score on a scale | Standard Deviation 4.87 |
| Intervention | Change in Autonomous Motivation for Stress Management | T2 (post-intervention) | 40.00 score on a scale | Standard Deviation 2.83 |
| Intervention | Change in Autonomous Motivation for Stress Management | T2 vs. T1 | 3.50 score on a scale | Standard Deviation 3.97 |
p-value: 0.8895% CI: [0.98, 6.02]t-test, 2 sided
Secondary
Change in Emotion Regulation
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Emotion Regulation | T1 (baseline) | 38.50 units on a scale | Standard Deviation 8.34 |
| Intervention | Change in Emotion Regulation | T2 (post-intervention) | 42.58 units on a scale | Standard Deviation 10.61 |
| Intervention | Change in Emotion Regulation | T2 vs. T1 | 4.08 units on a scale | Standard Deviation 5.74 |
p-value: 0.7195% CI: [0.43, 7.73]t-test, 2 sided
Secondary
Change in General Self-efficacy
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in General Self-efficacy | T1 (baseline) | 31.42 score on a scale | Standard Deviation 5.18 |
| Intervention | Change in General Self-efficacy | T2 (post-intervention) | 34.83 score on a scale | Standard Deviation 4.24 |
| Intervention | Change in General Self-efficacy | T2 vs. T1 | 3.42 score on a scale | Standard Deviation 5.88 |
p-value: 0.5895% CI: [-0.32, 7.16]t-test, 2 sided
Secondary
Change in Healthy Eating Self-efficacy
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Healthy Eating Self-efficacy | T1 (baseline) | 19.83 score on a scale | Standard Deviation 4.9 |
| Intervention | Change in Healthy Eating Self-efficacy | T2 (post-intervention) | 22.25 score on a scale | Standard Deviation 4.88 |
| Intervention | Change in Healthy Eating Self-efficacy | T2 vs. T1 | 2.42 score on a scale | Standard Deviation 3.96 |
p-value: 0.6195% CI: [-0.1, 4.94]t-test, 2 sided
Secondary
Change in Perceived Stress
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Perceived Stress | T2 (post-inbtervention) | 14.67 score on a scale | Standard Deviation 6.64 |
| Intervention | Change in Perceived Stress | T2 vs. T1 | -3.67 score on a scale | Standard Deviation 7.01 |
| Intervention | Change in Perceived Stress | T1 (baseline) | 18.33 score on a scale | Standard Deviation 6.1 |
p-value: -0.5295% CI: [-8.12, 0.79]t-test, 2 sided
Secondary
Change in Physical Activity Self-efficacy
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Physical Activity Self-efficacy | T1 (baseline) | 25.33 score on a scale | Standard Deviation 7.18 |
| Intervention | Change in Physical Activity Self-efficacy | T2 (post-intervention) | 29.17 score on a scale | Standard Deviation 7.41 |
| Intervention | Change in Physical Activity Self-efficacy | T2 vs. T1 | 3.83 score on a scale | Standard Deviation 8.39 |
p-value: 0.4695% CI: [-1.5, 9.16]t-test, 2 sided
Secondary
Daily Dietary Fat Intake
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
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Daily Dietary Fat Intake | T1 (baseline) | 34.59 Times fat consumed per day | Standard Deviation 4.93 |
| Intervention | Daily Dietary Fat Intake | T2 (post-intervention) | 31.17 Times fat consumed per day | Standard Deviation 5.06 |
| Intervention | Daily Dietary Fat Intake | T2 vs. T1 | -3.42 Times fat consumed per day | Standard Deviation 6.72 |
p-value: -0.5195% CI: [-7.69, 0.85]t-test, 2 sided
Secondary
Daily Fruit and Vegetable Intake
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
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Daily Fruit and Vegetable Intake | T1 (baseline) | 4.87 Times fruit/vegetable consumed per day | Standard Deviation 3.42 |
| Intervention | Daily Fruit and Vegetable Intake | T2 (post-intervention) | 5.72 Times fruit/vegetable consumed per day | Standard Deviation 3.43 |
| Intervention | Daily Fruit and Vegetable Intake | T2 vs. T1 | 0.85 Times fruit/vegetable consumed per day | Standard Deviation 1.75 |
p-value: 0.4995% CI: [-0.32, 2.03]t-test, 2 sided
Secondary
Daily Physical Activity (Metabolic Equivalent Task MET)
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.
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Daily Physical Activity (Metabolic Equivalent Task MET) | T1 (baseline) | 107.0 MET - Minutes per week | Standard Deviation 249.6 |
| Intervention | Daily Physical Activity (Metabolic Equivalent Task MET) | T2 (post-interveion) | 171.5 MET - Minutes per week | Standard Deviation 390 |
| Intervention | Daily Physical Activity (Metabolic Equivalent Task MET) | T2 vs. T1 | 64.46 MET - Minutes per week | Standard Deviation 504.1 |
p-value: 0.1395% CI: [-256, 384.7]t-test, 2 sided
Secondary
Frequency of Added Sugar Intake
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
Time frame: baseline (T1) and 3 weeks follow up (T2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Frequency of Added Sugar Intake | T1 (baseline) | 21.07 Times added sugar consumed per day | Standard Deviation 14.88 |
| Intervention | Frequency of Added Sugar Intake | T2 (post-intervention) | 12.53 Times added sugar consumed per day | Standard Deviation 8.32 |
| Intervention | Frequency of Added Sugar Intake | T2 vs. T1 | -8.54 Times added sugar consumed per day | Standard Deviation 17.88 |
p-value: -0.4895% CI: [-19.9, 2.82]t-test, 2 sided