Stress, Weight
Conditions
Brief summary
This research is being done is to evaluate the feasibility and acceptability of a novel weight loss mobile app that was designed to be less burdensome than traditional weight loss apps.
Detailed description
Obesity and stress are highly comorbid and both increase risk for cardiovascular disease (CVD). Stress is associated with disinhibited eating, junk food consumption and low consumption of produce and whole grains. Both stress and stress-induced eating are not only associated with obesity but also predict worst outcomes in lifestyle interventions. Stress and stress-induced eating should be targeted in interventions to maximize weight loss; however, this makes for a very intensive intervention. Technology could be leveraged to reduce intervention burden. In this trial investigators propose to compare the feasibility, usability, acceptability, and burden of an traditional weight loss app that includes diet and physical activity self-monitoring features to an app (Slip Buddy) we developed that focuses on self-monitoring of stress eating. With Slip Buddy, the user is just asked to track overeating episodes, indicating when they are triggered by stress. The majority of weight loss apps are burdensome to users by requiring them to self-monitor diet and exercise. They also ignore major barriers to weight loss, such as stress. This work moves the field forward by addressing user burden and an important barrier to weight loss.
Interventions
BEHAVIORALComprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity
The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
BEHAVIORALSimple Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Arm: Active Comparator: Simple Dietary Self-Monitoring he intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
Sponsors
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a BMI of 27-45 * Currently use an Android smartphone * Have cell phone connectivity at home and work * Uses a smartphone every day
Exclusion criteria
* Under the age of 18 and over the age of 65; * BMI under 27 or over 45; * Not interested in losing weight; * Does not currently own a smartphone; * Smartphone type and/or version not meeting app requirements; * No phone connectivity at home and work; * Unable to walk unaided for ¼ mile without stopping; * Has a condition that precludes dietary changes (i.e. ulcerative colitis, Crohn's disease, active diverticulitis, renal disease); * On a medication affecting weight; * Type 1 or 2 diabetes; * Had gastric bypass surgery; * Had or plans to have gastric bypass surgery during the study period; * Pregnant/lactating; * Has bipolar disorder, substance abuse, bulimia, or severe depression; * Lost 5% or more body weight in the last 3 months; * Has not experienced emotional eating over the last week; * On medication affecting weight; * Has concerns about being audiotaped; * Prisoner; * Unable to provide consent; or * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days App Used Over 12 Weeks | 12 weeks | App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period. |
| Usability | 12 weeks | Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends. |
| Acceptability | 12 weeks | Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree. |
| Burden | 12 weeks | At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change From Baseline to 12-Week Follow-Up | 12 weeks | A digital scale (Fitbit Aria) will be used to record weight. Percent weight change was calculated using weight at baseline and weight at 12-week follow-up. Missing values were calculated using last carry forward (LOCF). |
| Change in Emotional Eating From Baseline to 12-Week Follow-Up | 12 weeks | Three-Factory Eating Inventory is an 18-item measure and the emotional eating subscale consists of 3 items on a 4-point Likert scale. The score is derived by a multi-step equation. The range of scores for this subscale is 0-100, higher scores indicate higher emotional eating. |
| Change in Perceived Stress From Baseline to 12-Week Follow-Up | 12 weeks | The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress. |
Countries
United States
Participant flow
Pre-assignment details
After participants were initially screened, a telephone screening, webinar orientation and baseline survey was required prior to being randomized.
Participants by arm
| Arm | Count |
|---|---|
| Comprehensive Dietary Self-Monitoring The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments. | 32 |
| Simple Dietary Self-Monitoring The intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Comprehensive Dietary Self-Monitoring | Total | Simple Dietary Self-Monitoring |
|---|---|---|---|
| Age, Continuous | 40.2 years STANDARD_DEVIATION 12.3 | 39.8 years STANDARD_DEVIATION 11 | 39.5 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 59 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 55 Participants | 27 Participants |
| Region of Enrollment United States | 32 participants | 64 participants | 32 participants |
| Sex/Gender, Customized Selection of Gender Female | 24 Participants | 48 Participants | 24 Participants |
| Sex/Gender, Customized Selection of Gender Male | 7 Participants | 15 Participants | 8 Participants |
| Sex/Gender, Customized Selection of Gender Transmasculine Nonbinary | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 5 / 32 | 5 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Acceptability
Acceptability was assessed with a single item at 12 weeks assessing perceived helpfulness of the assigned app: Tracking my diet and exercise with MFP/slips with Slip Buddy was helpful (responses on a 5-point Likert scale from strongly disagree to strongly agree). Acceptability was indicated by responses of agree or strongly agree.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comprehensive Dietary Self-Monitoring | Acceptability | 77 percentage of participants |
| Simple Dietary Self-Monitoring | Acceptability | 39 percentage of participants |
p-value: 0.0027Chi-squared
Primary
Burden
At 12 weeks, participants were asked how burdensome the task of using their assigned application was on a scale of 0-100, 0 being not at all burdensome and 100 being very burdensome.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Comprehensive Dietary Self-Monitoring | Burden | 45.0 units on a scale |
| Simple Dietary Self-Monitoring | Burden | 30.0 units on a scale |
p-value: 0.7829Wilcoxon rank sum test
Primary
Percentage of Days App Used Over 12 Weeks
App use was measured for each condition using either backend data from Slip Buddy or reviewing MyFitnessPal entries indicating use over each 24-hour period.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Dietary Self-Monitoring | Percentage of Days App Used Over 12 Weeks | 57.5 percent of days app used | Standard Deviation 28.4 |
| Simple Dietary Self-Monitoring | Percentage of Days App Used Over 12 Weeks | 53.8 percent of days app used | Standard Deviation 31.3 |
Primary
Usability
Usability will be assessed using the System Usability Scale (SUS), a 10-item measure with 5-point Likert scale response options (Strongly Agree to Strongly Disagree). Scores are summed (0-40) then converted to a 0-100 scale, with higher scores indicating higher usability. Scores above 58 are considered above average, and scores above 80 are considered to indicate high usability where participants are likely to recommend the product to friends.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Dietary Self-Monitoring | Usability | 76.3 score on a scale | Standard Deviation 17.6 |
| Simple Dietary Self-Monitoring | Usability | 64.8 score on a scale | Standard Deviation 16.5 |
p-value: 0.0106t-test, 2 sided
Secondary
Change in Emotional Eating From Baseline to 12-Week Follow-Up
Three-Factory Eating Inventory is an 18-item measure and the emotional eating subscale consists of 3 items on a 4-point Likert scale. The score is derived by a multi-step equation. The range of scores for this subscale is 0-100, higher scores indicate higher emotional eating.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Dietary Self-Monitoring | Change in Emotional Eating From Baseline to 12-Week Follow-Up | -1.1 change in score from baseline 12 weeks | Standard Deviation 25.5 |
| Simple Dietary Self-Monitoring | Change in Emotional Eating From Baseline to 12-Week Follow-Up | -9.9 change in score from baseline 12 weeks | Standard Deviation 25.1 |
Secondary
Change in Perceived Stress From Baseline to 12-Week Follow-Up
The Perceived Stress Scale is a 14-item measure of perceived stress. Scores range from 0-56, higher scores indicate higher perceived stress.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Dietary Self-Monitoring | Change in Perceived Stress From Baseline to 12-Week Follow-Up | 2.8 score on a scale | Standard Deviation 9.1 |
| Simple Dietary Self-Monitoring | Change in Perceived Stress From Baseline to 12-Week Follow-Up | 2.5 score on a scale | Standard Deviation 6.8 |
Secondary
Percent Weight Change From Baseline to 12-Week Follow-Up
A digital scale (Fitbit Aria) will be used to record weight. Percent weight change was calculated using weight at baseline and weight at 12-week follow-up. Missing values were calculated using last carry forward (LOCF).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comprehensive Dietary Self-Monitoring | Percent Weight Change From Baseline to 12-Week Follow-Up | -3.6 percent weight | Standard Deviation 4.9 |
| Simple Dietary Self-Monitoring | Percent Weight Change From Baseline to 12-Week Follow-Up | -3.0 percent weight | Standard Deviation 4.5 |