Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03367936 |
| Other study ID # |
PRO17040453 |
| Secondary ID |
1R01HL131583-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2018 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
