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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03367936
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : April 2, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Lora Burke, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date April 2, 2021
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
  • Adherence to behavioral goals [ Time Frame: 6 and 12 months ]
    Number of days participants met the dietary and physical activity goals
  • Adherence to self-weighing [ Time Frame: 6 and 12 months ]
    Number of days participants self-weigh
  • Adherence to treatment protocol [ Time Frame: 6 and 12 months ]
    Number of days participants self-monitor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 8, 2017)
Retention [ Time Frame: 6 and 12 months ]
The percentage of participants who stay in the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Promoting Lifestyle Change Via Tailored mHealth Feedback to Improve Health
Official Title  ICMJE 12 Months Weight Loss Study Using Feedback Messages Delivered Via Smartphone
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.
Detailed Description

This study includes the following activities:

  1. Screening:

    Phase I: It will be conducted online. Respondents to recruitment solicitations will be provided an online Uniform Resource Locator (URL) with a hyperlink to a study flier that describes the essential elements of the study. It will also include a choice of URL or Quick Response (QR) code to access an online survey that will provide more details about the study. The research staff will also ask preliminary questions about eligibility (age, height and weight to calculate BMI), and consent to have the research team review the participant's answers.

    Phase II: It will be conducted online. After completing an online consent, the participants will provide personal information in the Sociodemographic and Lifestyle Questionnaire and health and medical conditions in the General Health History questionnaire as well as the Center for Epidemiologic Studies Depression Scale (CES-D) and the Eating Habits Checklist to screen for eating disorders.

    Run-in period: To minimize attrition and ensure that potential subjects are appropriate for the intervention, research staff will teach all eligible individuals how to download and complete a 5-day Self-Monitoring diary using the My Food Diary (Fitbit) Self-Monitoring program on the participant's phone or computer. After review of the diary, research staff will contact the potential participant to schedule the baseline assessment. Individuals need to record at least 700 kcal/day of food intake to be eligible for the study. Each user will have a username and password and also have the ability to manage the participant's own privacy settings.

    Baseline Assessment: Individuals who remain eligible will be invited to a screening appointment where the investigators measure the participant's height/weight for BMI, and explain the aims of the study and the 2 group conditions. If interested in participating, attendees will be asked to sign a consent form for the baseline data collection. At this visit, the participants will be asked to complete the Barriers to Healthy Eating scale; Weight Efficacy Lifestyle (WLE); Self-Efficacy and Eating Habits Survey; Self-Efficacy and Exercise Habits Survey; Self-Regulation of Eating Behavior Questionnaire; a one-page questionnaire (Quick WAVE140) that assesses current diet and PA habits, PROMIS Sleep Disturbance Short Form 8a; Effort-Reward Imbalance questionnaire; and ASA-24 Dietary Recall (two different days) . At the end of the baseline assessment, participants will be scheduled for a One-on-One session with a master's prepared registered dietician who will conduct an interview WAVE screener and provide counseling regarding lifestyle habits that support weight loss.

  2. Randomization:

    At the One-on-One session, the research staff will use a computer software program on a laptop to determine to which group the individual will be randomized. (Prior to this time, the randomization scheme will be implemented via a computerized program (Visual Basic 6.0) using minimization method, which will be overseen by a statistician (Co-PI: S Sereika). Each of the 2 conditions (Self-Monitoring alone or Self-Monitoring plus Feedback) will be assigned a total of 265 subjects with randomization stratified by gender and race. After randomization, all participants will receive instructions on using the Fitbit Charge 2™ for physical activity and the Withings or Fitbit scale for self-weighing.

  3. Intervention:

    The intervention will consist of the Self-Monitoring and Feedback program and remote guidance to a lifestyle program for weight loss. All participants will be subscribed to My Food Diary an online Self-Monitoring program that can be accessed via the participant's smartphone or any computer. The interventionists will have access to the diaries so the study staff can contact a participant if there is any safety concern about the reported eating behaviors. The study will provide all participants a wrist-worn FitBit Charge 2™ to self-monitor the participant's physical activity which synchs with the participant's phone or computer. The study will also provide all participants a Bluetooth-enabled scale (Withings or Fitbit) for self-monitoring the participant's weight. The Withings scale will transmit the weight values to the smartphone, Health Mate app and server, so the research team will know the weight status of participants. The Fitbit scale will transmit weights to the Fitbit server and then to the participant's phone so that study staff can monitor weight. The subject registers as the primary scale user and is subsequently recognized and distinguished from other household users. The scale displays the weight accurately to the 10th decimal. The data are converted to graphs for easy review. Batteries have a 6-12 month life. The scale measures weights between 5 and 180 kg. Participants will weigh themselves with the device daily; participants will be able to view the participant's weight data on the participant's smartphone. The Fitbit will provide data on daily steps and distance walked, which will be used to inform the selection of message that the investigators will provide participants in the Self-Monitoring plus Feedback group feedback messages related to physical activity. The data that will be transmitted between the Fitbit and Pitt servers will not contain any identifying personal information nor will Fitbit store any identifying information for the participants.

    Self-Monitoring group (Control Group): Individuals in this condition will not receive Feedback messages. All subjects will use a smartphone to self-monitor diet (My Food Diary), Fitbit Charge 2™ to monitor PA, and a Withings/Fitbit digital scale for weight. The Fitbit app is publically available. At the baseline visit following randomization, participants will be oriented to Self-Monitoring and the various Self-Monitoring devices and apps, and provided a tutorial with images shown on the laptop and devices as well as printed materials showing the screen shots. At this baseline session, each participant will have a one-on-one session with the project interventionist which covers the core principles of behavioral weight loss to ensure all understand basic recommendations for safe and effective weight loss. The participants also will be given personalized fat, calorie, and physical activity 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/).

    Self-Monitoring+Feedback (Intervention Group)-This group 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. it will be tailored to each participant's progress based on standardized algorithms. At the baseline visit following randomization, participants will be oriented to Self-Monitoring and the various Self-Monitoring devices and apps, and provided a tutorial with images shown on the laptop and devices as well as printed materials showing the screen shots. In addition, the Feedback program will be explained to them and how this is responsive to information entered on the Self-Monitoring diaries. Also, the participants will be given a brief handout on fat, calorie, physical activity and weight goals for weight loss and information about how to access the intervention materials from the Diabetes Prevention Program (DPP) online.

    The research team is able to review the Self-Monitoring data, and will check the data weekly. If any indication of rapid weight loss or periods of inactivity occur, research staff will contact the subject.

  4. Measurements used in Study: At Phase I and II Screening: Medical and Weight History Form, Sociodemographic Form, Binge Eating Scale (Eating Habits Checklist), Center for Epidemiologic Studies Depression (CES-D); At baseline, 6 and 12 months: Weight (Withings or Fitbit scale, smartphone), blood pressure, waist circumference, Self-Regulation of Eating Behavior Questionnaire (SREBQ), Barriers to Healthy Eating (BHE), Weight Efficacy Lifestyle (WEL), Self- Efficacy and Eating Habits Survey, Self-Efficacy and Exercise Habits Survey, Quick WAVE Screener Questionnaire, PROMIS Sleep Disturbance, Effort-Reward Imbalance Questionnaire, diet (24-Hour Dietary Recall & smartphone), PA (The FitBit Charge 2™, smartphone), Intervention Satisfaction Questionnaire (at 12 months only).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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/).
    Interventions:
    • Behavioral: One-on-one Session
    • Behavioral: Self-monitoring
  • 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.
    Interventions:
    • Behavioral: One-on-one Session
    • Behavioral: Self-monitoring
    • Behavioral: Feedback
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2020)
502
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
530
Actual Study Completion Date  ICMJE March 31, 2021
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03367936
Other Study ID Numbers  ICMJE PRO17040453
1R01HL131583-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share the data.
Responsible Party Lora Burke, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP