NCT02344836

Brief Summary

Smartphones have the capability to monitor health-related behaviors (exercise, diet, etc.) and provide social support which has the potential to play a powerful role in health promotion. The objective of this study is to refine and pilot test the Social POD app for personalized health monitoring and interaction founded on a combination of social networks, recommender systems, motivational research, and health behavior theory. The aim of our proposed project is to conduct a 3-month pilot RCT among overweight and obese adults (N=150) comparing a theory-based podcast (TBP) plus self-monitoring using a commercially-available calorie and weight tracking app (current most popular diet self-monitoring method) versus TBP plus self-monitoring and social support/incentive points for participating with the Social POD app (TBP+Social POD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 obesity

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

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

January 16, 2015

Last Update Submit

June 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    12 weeks

Study Arms (2)

Theory-based podcast

ACTIVE COMPARATOR

Receive a 3-month weight loss intervention delivered via theory-based podcast (TBP) plus self-monitoring using a commercially-available calorie and weight tracking app (current most popular diet self-monitoring method). Intervention: podcast + mobile diet app

Behavioral: Podcast + mobile diet app

Theory-based podcast + Social POD

EXPERIMENTAL

Receive a 3-month weight loss intervention delivered via Theory-based Podcast (TBP) plus self-monitoring and social support/incentive points for participating with the Social POD app (TBP+Social POD). Intervention: podcast + theory-based mobile diet app

Behavioral: Podcast + theory-based mobile diet app

Interventions

Use of a mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.

Theory-based podcast

Use of a theory-based mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.

Theory-based podcast + Social POD

Eligibility Criteria

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

You may qualify if:

  • Overweight or obese (Body Mass Index between 25 and 49.9 kg/m2)
  • Own and Android phone or tablet

You may not qualify if:

  • are currently pregnant
  • are younger than 18 or older than 65 years of age
  • are unable to attend 3 meetings at the University of South Carolina
  • don't have access to the Internet and a computer
  • don't have access to a scale for self-monitoring weight
  • aren't willing to be randomized to one of the two groups
  • have a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
  • have a major health condition, such as heart conditions, diabetes, and past incidence of stroke
  • have an eating disorder
  • currently participating in a weight loss program or taking weight loss medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (2)

  • Hales S, Turner-McGrievy GM, Wilcox S, Davis RE, Fahim A, Huhns M, Valafar H. Trading pounds for points: Engagement and weight loss in a mobile health intervention. Digit Health. 2017 Apr 24;3:2055207617702252. doi: 10.1177/2055207617702252. eCollection 2017 Jan-Dec.

  • Hales S, Turner-McGrievy GM, Wilcox S, Fahim A, Davis RE, Huhns M, Valafar H. Social networks for improving healthy weight loss behaviors for overweight and obese adults: A randomized clinical trial of the social pounds off digitally (Social POD) mobile app. Int J Med Inform. 2016 Oct;94:81-90. doi: 10.1016/j.ijmedinf.2016.07.003. Epub 2016 Jul 2.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations