NCT03865342

Brief Summary

This study will test the weight loss efficacy of a mobile diabetes prevention program intervention. Half of the sample of prediabetic adults will receive the virtual DPP and half will receive usual medical care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

March 4, 2019

Last Update Submit

April 4, 2023

Conditions

PreDiabetes

Keywords

mHealthDiabetes Prevention Programweight lossbody weightbehavioral interventions

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Body weight recorded during follow-up appointments at the medical clinic.

    Baseline, 6, and 12 months

Secondary Outcomes (1)

  • Change in hemoglobin A1c

    Baseline, 6, and 12 months

Other Outcomes (2)

  • Change in work productivity

    Baseline, 6, and 12 months

  • Change in quality of life

    Baseline, 6, and 12 months

Study Arms (2)

Noom Coach DPP

EXPERIMENTAL

Individuals will receive special instructions on how to use the app and will self-monitor their weight, exercise and receive daily DPP core content through the app over 16 weeks plus guidance from a coach, and will thereafter receive post-core DPP content up to 52 weeks.

Behavioral: Noom Coach DPP

Usual Care

NO INTERVENTION

The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period plus a paper version of the DPP curriculum.

Interventions

Noom Coach DPPBEHAVIORAL

Subjects receiving the smartphone app will receive the DPP core curriculum for 16 weeks and then the post-core curriculum for 36 weeks through the app. The Noom mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve DPP goals. The participant can log their food intake, weight, steps, exercise, in addition to participating in the DPP group interaction through the application.

Noom Coach DPP

Eligibility Criteria

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

You may qualify if:

  • English-speaking
  • years of age and older
  • Referral from the patient's physician
  • Hemoglobin A1C: 5.7 - 6.4 within the 3 months prior to enrollment
  • Own a smartphone (Apple or Android)

You may not qualify if:

  • Recent weight loss (by patient report, \>5 lbs in the 6 months preceding enrollment visit)
  • previous diagnosis of type 1 or type 2 diabetes
  • serious or persistent mental illnesses
  • more than 72 hours of hospitalization in the last 30 days
  • Enrollment in a structured weight-loss program currently or within the 1 month preceding study enrollment
  • Pregnant
  • Currently nursing
  • Have given birth within the past 3 months
  • Has been discouraged by a physician to enroll in a DPP program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • Toro-Ramos T, Michaelides A, Anton M, Karim Z, Kang-Oh L, Argyrou C, Loukaidou E, Charitou MM, Sze W, Miller JD. Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 8;8(7):e17842. doi: 10.2196/17842.

    PMID: 32459631DERIVED

MeSH Terms

Conditions

Prediabetic StateWeight LossBody Weight

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBody Weight ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joshua D Miller, MD, MPH

    Stony Brook University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

September 1, 2016

Primary Completion

June 25, 2018

Study Completion

June 25, 2018

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)