NCT03367936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2021

Enrollment Period

2.7 years

First QC Date

December 5, 2017

Last Update Submit

April 9, 2025

Conditions

Overweight and Obesity

Keywords

mobile technologyfeedback messageself-monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Changes in weight: measured as percent change in weight from baseline to 6 and 12 months

    6 and 12 months

Secondary Outcomes (3)

  • Adherence to behavioral goals

    6 and 12 months

  • Adherence to self-weighing

    6 and 12 months

  • Adherence to treatment protocol

    6 and 12 months

Other Outcomes (1)

  • Retention

    6 and 12 months

Study Arms (2)

Self-monitoring group

ACTIVE COMPARATOR

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 SessionBehavioral: Self-monitoring

Self-monitoring+Feedback group

EXPERIMENTAL

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 SessionBehavioral: Self-monitoringBehavioral: Feedback

Interventions

One-on-one SessionBEHAVIORAL

Participants will receive a 45-minute one-on-one behavioral lifestyle program for a healthful lifestyle and weight loss.

Self-monitoring groupSelf-monitoring+Feedback group
Self-monitoringBEHAVIORAL

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

Self-monitoring groupSelf-monitoring+Feedback group
FeedbackBEHAVIORAL

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

Self-monitoring+Feedback group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Presence of an unstable condition requiring physician-supervised diet and exercise (e.g., recent myocardial infarction);
  • Physical limitations precluding ability to engage in moderate-intensity physical activity;
  • Pregnancy or intention to become pregnant during study;
  • Current treatment for a serious mental illness (e.g. schizophrenia);
  • Reported alcohol intake \> 4 drinks/day;
  • Participation in a formal weight loss program, loss of ≥ 5% weight in past 6 month, or current use of weight loss medication;
  • History of bariatric surgery in \<5 years,
  • Planned extended vacations, absences, or relocation during study;
  • A score \>16 on the Center for Epidemiologic Studies Depression Scale (CES-D);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (5)

  • Cheng J, Costacou T, Sereika SM, Conroy MB, Parmanto B, Rockette-Wagner B, Kriska AM, Klem ML, Burke LE. Effect of an mHealth weight loss intervention on Healthy Eating Index diet quality: the SMARTER randomised controlled trial. Br J Nutr. 2023 Dec 14;130(11):2013-2021. doi: 10.1017/S0007114523001137. Epub 2023 Jun 7.

    PMID: 38713063DERIVED

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PMID: 38375882DERIVED

  • Bizhanova Z, Sereika SM, Brooks MM, Rockette-Wagner B, Kariuki JK, Burke LE. Identifying Predictors of Adherence to the Physical Activity Goal: A Secondary Analysis of the SMARTER Weight Loss Trial. Med Sci Sports Exerc. 2023 May 1;55(5):856-864. doi: 10.1249/MSS.0000000000003114. Epub 2022 Dec 28.

    PMID: 36574734DERIVED

  • Burke LE, Sereika SM, Bizhanova Z, Parmanto B, Kariuki J, Cheng J, Beatrice B, Cedillo M, Pulantara IW, Wang Y, Loar I, Conroy MB. The Effect of Tailored, Daily, Smartphone Feedback to Lifestyle Self-Monitoring on Weight Loss at 12 Months: the SMARTER Randomized Clinical Trial. J Med Internet Res. 2022 Jul 5;24(7):e38243. doi: 10.2196/38243.

    PMID: 35787516DERIVED

  • Burke LE, Sereika SM, Parmanto B, Bizhanova Z, Kariuki JK, Cheng J, Beatrice B, Loar I, Pulantara IW, Wang Y, Cedillo M, Conroy MB. Effect of tailored, daily feedback with lifestyle self-monitoring on weight loss: The SMARTER randomized clinical trial. Obesity (Silver Spring). 2022 Jan;30(1):75-84. doi: 10.1002/oby.23321. Epub 2021 Dec 12.

    PMID: 34898011DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing and Epidemiology

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 11, 2017

Study Start

August 1, 2018

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

April 13, 2025

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

There is no plan to share the data.

Locations

US(1)