StressNCT02615171

RELAX: A Mobile Application Suite Targeting Obesity and Stress

A study testing Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity and Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity in people with Stress and Weight, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Stress, Weight
What is being tested?: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity and Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2019to 30 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have a BMI of 27-45
Currently use an Android smartphone
Have cell phone connectivity at home and work
Uses a smartphone every day

Who cannot join

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;

Show all 21Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Connecticut
Storrs, Connecticut, 06269

Other trials in United States

About this study

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.

Read the 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.

Conditions: Stress, Weight
Being tested: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity, Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Medical subject headings: Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activityBehavioural
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.
Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activityBehavioural
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.

Study groups in NCT02615171
Study group	Role	What they receive
Comprehensive Dietary Self-Monitoring	Active comparator	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. Receives: Behavioral: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity
Simple Dietary Self-Monitoring	Active comparator	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. Receives: Behavioral: Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks

Secondary outcomes (3)

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).
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201930 Nov 2019

First posted26 Nov 2015 (estimated)
Study start8 Jul 2019
Primary completion30 Nov 2019
Study completion30 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02615171
Sponsor's protocol ID: H17-217
Other IDs: 1R01HL122302-01A1
Status last verified: Mar 2021
First submitted: 19 Nov 2015
Last updated: 13 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pagoto S, Tulu B, Waring ME, Goetz J, Bibeau J, Divito J, Groshon L, Schroeder M. Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24249. doi: 10.2196/24249.
PubMed 33792547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RELAX: A Mobile Application Suite Targeting Obesity and Stress
ClinicalTrials.gov ID: NCT02615171
Acronym / sponsor ID: H17-217
Conditions: Stress, Weight
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: Worcester Polytechnic Institute, National Heart, Lung, and Blood Institute (NHLBI)
Study start: 8 Jul 2019 (actual)
Primary completion: 30 Nov 2019 (actual)
Study completion: 30 Nov 2019 (actual)
First posted: 26 Nov 2015 (estimated)
Results: Posted 11 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Comprehensive Dietary Self-Monitoring	Active comparator	Behavioral: Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activityThe 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.
Simple Dietary Self-Monitoring	Active comparator	Behavioral: Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activityThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have a BMI of 27-45
Currently use an Android smartphone
Have cell phone connectivity at home and work
Uses a smartphone every day

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activityThe 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.	Behavioural	Comprehensive Dietary Self-Monitoring
Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activityArm: 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.	Behavioural	Simple Dietary Self-Monitoring

Primary outcome

Percentage of Days App Used Over 12 Weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

3 secondary outcomes

Percent Weight Change From Baseline to 12-Week Follow-Up
Time frame: 12 weeks
Change in Perceived Stress From Baseline to 12-Week Follow-Up
Time frame: 12 weeks
Change in Emotional Eating From Baseline to 12-Week Follow-Up
Time frame: 12 weeks

Results and safety

Results posted to the registry on 11 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comprehensive Dietary Self-Monitoring	32	30
Simple Dietary Self-Monitoring	32	31

Primary outcome: Percentage of Days App Used Over 12 Weeks

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percent of days app used

Measure	Comprehensive Dietary Self-Monitoring n = 32	Simple Dietary Self-Monitoring n = 32
Value	57.5 (28.4)	53.8 (31.3)

Primary outcome: Usability

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Comprehensive Dietary Self-Monitoring n = 30	Simple Dietary Self-Monitoring n = 31
Value	76.3 (17.6)	64.8 (16.5)

Comprehensive Dietary Self-Monitoring vs Simple Dietary Self-Monitoring: p = 0.0106, t-test, 2 sided

Primary outcome: Acceptability

Time frame: 12 weeks. Number. Unit: percentage of participants

Measure	Comprehensive Dietary Self-Monitoring n = 30	Simple Dietary Self-Monitoring n = 31
Value	77	39

Comprehensive Dietary Self-Monitoring vs Simple Dietary Self-Monitoring: p = 0.0027, Chi-squared

Primary outcome: Burden

Time frame: 12 weeks. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Comprehensive Dietary Self-Monitoring n = 30	Simple Dietary Self-Monitoring n = 31
Value	45.0 (10.0 to 60.0)	30.0 (15.0 to 50.0)

Comprehensive Dietary Self-Monitoring vs Simple Dietary Self-Monitoring: p = 0.7829, Wilcoxon rank sum test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the period of 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comprehensive Dietary Self-Monitoring	0 of 32 (0%)	5 of 32 (15.6%)	0 of 32
Simple Dietary Self-Monitoring	0 of 32 (0%)	5 of 32 (15.6%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33792547Pagoto S, Tulu B, Waring ME, Goetz J, Bibeau J, Divito J, Groshon L, Schroeder M. Slip Buddy App for Weight Management: Randomized Feasibility Trial of a Dietary Lapse Tracking App. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e24249. doi: 10.2196/24249.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Days App Used Over 12 Weeks (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615171, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.