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Promoting Lifestyle Change Via Tailored mHealth Feedback to Improve Health (SMARTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03367936
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Lora Burke, University of Pittsburgh

Brief Summary:
The overall purpose of this randomized clinical trial is to examine the effect and efficacy of the individualized, real-time, smartphone-based feedback of diet and physical activity self-monitoring on subsequent weight-control behaviors, weight loss outcomes and sustainability of patient engagement. Participants will be randomized to one of 2 groups: (1) Self-Monitoring -similar to what many people do on their own, subjects will self-monitor diet, physical activity using Fitbit and weight using a Bluetooth-enabled scale, and (2) Self-Monitoring +Feedback-participants will self-monitor as described for the Self-Monitoring group but also will receive tailored Feedback messages. The Self-Monitoring +Feedback participants will receive up to 4 daily discrete pop-up Feedback messages on the participant's smartphone delivered at random times during waking hours and tailored to content of recorded entries in the subjects' smartphone-based diaries and a weekly summary Feedback message about the participant's weight.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: One-on-one Session Behavioral: Self-monitoring Behavioral: Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12 Months Weight Loss Study Using Feedback Messages Delivered Via Smartphone
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Self-monitoring group
All subjects will use a smartphone to self-monitor diet and monitor physical activity (Fitbit Charge 2), and a Withings or Fitibit digital scale for weight. Following randomization, participants will be oriented to Self-monitoring and provided a tutorial with images shown on the laptop and devices as well as printed materials showing the screen shots. At baseline, each participant will have a one-on-one session with the project interventionist, which covers the core principles of behavioral weight loss. The participant also will be given personalized fat, calorie, and PA goals for weight loss and information about how to access the intervention materials from the Diabetes Prevention Program (DPP) online which is publicly available (https://www.diabetesprevention.pitt.edu/).
Behavioral: One-on-one Session
Participants will receive a 45-minute one-on-one behavioral lifestyle program for a healthful lifestyle and weight loss.

Behavioral: Self-monitoring
Participants will receive an orientation on how to self-monitor using the smartphone and other devises

Experimental: Self-monitoring+Feedback group
All subjects will be asked to do everything the self-monitoring group is asked to do. Subjects will receive up to 4 Feedback messages per day (messages will be delivered between the hours set by the participants on the participant's phone, e.g., 8 AM and 9:30 PM). Messages will be delivered automatically, remotely and in real-time. Messages will be tailored to each participant's progress based on standardized algorithms. The Feedback program will be explained to them and how this is responsive to information entered on the self-monitoring diaries.
Behavioral: One-on-one Session
Participants will receive a 45-minute one-on-one behavioral lifestyle program for a healthful lifestyle and weight loss.

Behavioral: Self-monitoring
Participants will receive an orientation on how to self-monitor using the smartphone and other devises

Behavioral: Feedback
Participants will receive up to 4 daily feedback messages based on progress in attaining target behavior. The feedback messages will be delivered on a variable ratio schedule and tailored to data in subjects' dietary recordings




Primary Outcome Measures :
  1. Change in weight [ Time Frame: 6 and 12 months ]
    Changes in weight: measured as percent change in weight from baseline to 6 and 12 months


Secondary Outcome Measures :
  1. Adherence to behavioral goals [ Time Frame: 6 and 12 months ]
    Number of days participants met the dietary and physical activity goals

  2. Adherence to self-weighing [ Time Frame: 6 and 12 months ]
    Number of days participants self-weigh

  3. Adherence to treatment protocol [ Time Frame: 6 and 12 months ]
    Number of days participants self-monitor


Other Outcome Measures:
  1. Retention [ Time Frame: 6 and 12 months ]
    The percentage of participants who stay in the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Currently own and regularly use a smartphone
  2. Age ≥18 years;
  3. BMI > 27 and < 43; and
  4. Successful completion of a 5-day electronic diary of food intake during a run-in period.

Exclusion Criteria:

  1. Presence of an unstable condition requiring physician-supervised diet and exercise (e.g., recent myocardial infarction);
  2. Physical limitations precluding ability to engage in moderate-intensity physical activity;
  3. Pregnancy or intention to become pregnant during study;
  4. Current treatment for a serious mental illness (e.g. schizophrenia);
  5. Reported alcohol intake > 4 drinks/day;
  6. Participation in a formal weight loss program, loss of ≥ 5% weight in past 6 month, or current use of weight loss medication;
  7. History of bariatric surgery in <5 years,
  8. Planned extended vacations, absences, or relocation during study;
  9. A score >16 on the Center for Epidemiologic Studies Depression Scale (CES-D);
  10. Score >32 on the Eating Habits Checklist, an eating disorder scale administered at baseline. For those who have an elevated BDI score (>22) or EHC (>32), we offer referral for counseling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367936


Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Lora Burke, PhD MPH    412-624-2305    lbu100@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Lora Burke, Professor of Nursing and Epidemiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03367936    
Other Study ID Numbers: PRO17040453
1R01HL131583-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lora Burke, University of Pittsburgh:
mobile technology
feedback message
self-monitoring
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms