NCT04708769

Brief Summary

The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
524

participants targeted

Target at P75+ for not_applicable obesity

Timeline
2mo left

Started Mar 2021

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress98%
Mar 2021Jul 2026

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Expected
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

January 12, 2021

Last Update Submit

April 30, 2026

Conditions

Obesity

Keywords

Weight LossDietPhysical ActivitySelf MonitoringMobile Health

Outcome Measures

Primary Outcomes (1)

  • Weight

    Participant change in weight, in kilograms, from baseline to 6-months.

    Baseline to 6-Months

Secondary Outcomes (1)

  • Costs of treatment

    12 Months

Study Arms (2)

Smartphone App Participants (APP)

EXPERIMENTAL

Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist

Behavioral: Smartphone App Participants (APP)

Diabetes Prevention Program Participants (DPP)

EXPERIMENTAL

Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist

Behavioral: Diabetes Prevention Program Participants (DPP)

Interventions

Smartphone App Participants (APP)BEHAVIORAL

Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.

Smartphone App Participants (APP)
Diabetes Prevention Program Participants (DPP)BEHAVIORAL

In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.

Diabetes Prevention Program Participants (DPP)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 30-45
  • Weight stable
  • Own a Smartphone and be willing to install our Smartphone app
  • Willing to conduct video conference calls with study staff

You may not qualify if:

  • Enrolled in any formal weight loss program
  • Taking anti-obesity medications
  • Not taking medications that may cause weight gain
  • Unstable medical conditions
  • Diabetes requiring insulin supplementation
  • Crohn's Disease
  • Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
  • Assistive devices for mobility
  • Hospitalizations for a psychiatric disorder within the past 5 years
  • Cardiovascular disease symptoms while performing moderate intensity exercise
  • Pregnancy, trying to get pregnant, or lactating.
  • Bulimia or binge eating disorder
  • Reports of active suicidal ideation
  • Current substance abuse or dependence besides nicotine dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

ObesityWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Angela Pfammatter, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

March 16, 2021

Primary Completion

December 15, 2025

Study Completion (Estimated)

July 10, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)