NCT03283618

Brief Summary

As the prevalence and associated healthcare costs of obesity continue to increase, the need for obesity treatments that contribute to weight loss maintenance are needed. Through the functionality of a smart device, telehealth can provide quality healthcare to individuals of different socioeconomic communities, expand healthcare access, as well as reduce overall healthcare costs. This research program will uncover the effects of a 12-week commercially available telehealth-based weight management program (inHealth Medical Services, Inc.) on body weight, blood pressure, and steps.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Nov 2015

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

November 16, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

September 13, 2017

Last Update Submit

September 13, 2017

Conditions

ObesityWeight LossTelemedicine

Keywords

Weight lossVideo conferencingHealth coachingTelemedicinemHealthObesity

Outcome Measures

Primary Outcomes (1)

  • Body weight loss (kg)

    The investigators examined body weight changes between groups baseline (week 0) and post intervention (week12).

    Change in body weight between week 0 and week 12

Secondary Outcomes (4)

  • Comparison of daily step average per day by group.

    Change in average steps per day between week 0 and week 12

  • Comparison of resting systolic and diastolic blood pressure average per day by group.

    Change in systolic and diastolic blood pressure per day between week 0 and week 12

  • Quality of Life change from pre to post intervention.

    Pre and Post (a 12 week study)

  • Dietary Quality change from pre to post intervention.

    Pre and Post (a 12 week study)

Study Arms (2)

Control Group

NO INTERVENTION

The control group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) as well as caloric and step goals, but no health coaching. They will complete the same pre- and post-intervention measurements and consultations with the medical doctor and registered dietitian.

Video Conference-based Health Coaching

EXPERIMENTAL

The video conference-based health coaching group will receive the mHealth devices (scale, blood pressure cuff, and accelerometer watch) meet the medical doctor at baseline and at 12 weeks via the Amwell® app using their smartphone. The participants will receive health coaching by meeting weekly (12 times) with the registered dietitian (RD) to discuss behavior modification, exercise, and nutrition goals.

Behavioral: Video Conferencing Group

Interventions

Video Conferencing GroupBEHAVIORAL
Video Conference-based Health Coaching

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Virginia Gray, PhD, RD

    California State University, Long Beach

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Following baseline visits, participants were randomized to a video conference or control groups.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: All subjects were randomized in a balanced fashion and stratified by sex into either one of the two groups video conferencing or a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 14, 2017

Study Start

November 16, 2015

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09