NCT02812264

Brief Summary

This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

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

June 10, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

June 7, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

June 10, 2016

Last Update Submit

July 13, 2020

Conditions

Weight LossHealth Behavior

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Change in body weight over course of study

    up to 12 months

Secondary Outcomes (16)

  • Weight Change - 3 months

    up to 3 months

  • Weight Change - 6 months

    up to 6 months

  • Automated Self-Administered 24-hour Dietary recall (ASA-24)

    baseline, 3-, 6-, 12-months

  • Physical Activity

    baseline, 3-, 6-, 12-months

  • Blood Pressure

    baseline, 3-, 6-, 12-months

  • +11 more secondary outcomes

Study Arms (2)

API App

EXPERIMENTAL

use of API weight loss mobile application for 12 months, plus fitness tracker and scale.

Behavioral: API AppBehavioral: fitness trackerBehavioral: scale

Attention Control

ACTIVE COMPARATOR

use of non-API app for weight loss over 12 months, plus fitness tracker and scale.

Behavioral: Non-API AppBehavioral: fitness trackerBehavioral: scale

Interventions

API AppBEHAVIORAL

Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale

API App
Non-API AppBEHAVIORAL

Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.

Attention Control
fitness trackerBEHAVIORAL

fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app

Also known as: wearable
API AppAttention Control
scaleBEHAVIORAL

Connected scale that will transfer weight information to app

Also known as: weight
API AppAttention Control

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • between 21-65 years old
  • BMI between 25-40 kg/m2
  • ownership and use of an Android smartphone during past 6 months with no plans to change phone/service during study
  • consent for research team to monitor app utilization

You may not qualify if:

  • use of weight loss medication
  • prior or planned bariatric surgery
  • psychiatric hospitalization in past 12 months
  • pregnancy, nursing, or planned pregnancy during the study
  • history of cardiovascular disease (CVD) event
  • self-reported history of an eating disorder
  • use of medication for diabetes mellitus
  • mobility restrictions for which exercise is contraindicated
  • history of a condition (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated
  • current participation in another weight treatment study and/or recent weight loss \>10%
  • investigator discretion for safety reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coeus Health Offices

State College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Weight LossHealth Behavior

Interventions

Fitness TrackersWeights and Measures

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and SuppliesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants will not know which arm they have been randomized to. Additionally, the investigators will be blinded to participant assignment. Randomization will be completed by the program manager.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 24, 2016

Study Start

June 7, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

US(1)