NCT01650337

Brief Summary

BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed. In March 2012, experts estimated that 40,000 health related smartphone applications were on the market but little is known about the effectiveness of these programs. To our knowledge, no studies have evaluated whether weight loss can be successfully achieved through use of a smartphone application or how these applications could be used in primary care practice. PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight loss and calorie counting in a primary care setting. METHODS: The first phase of this study involved a community based participatory approach to select the intervention. Patient focus groups were conducted and analyzed to explore patients' preferences regarding various text-message versus smartphone programs. The second phase of this study, described here, will be a randomized controlled trial with overweight primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2) usual care plus smartphone application, which includes instructing participants on how to use the application and encouraging them to use the applications' reminders and social networking features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as appropriate. ANCOVA models will be used to examine weight change after adjusting for covariates such as education, sex and age. Repeated measures analysis will be carried out to compare weight change between the groups using baseline, 3 month and 6 month data. In addition to an intent-to-treat analysis, the investigators will also conduct a "treatment received" analysis, adjusting for the extent of application use in both the intervention and control arms. CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in primary care settings and incorporated into the visit can produce weight loss. Study findings could inform a national discourse on the value of smartphone applications in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

July 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

9 months

First QC Date

July 23, 2012

Last Update Submit

June 2, 2013

Conditions

OverweightObese

Outcome Measures

Primary Outcomes (1)

  • weight loss

    six months

Secondary Outcomes (1)

  • systolic blood pressure

    six months

Other Outcomes (1)

  • Self-efficacy in dieting

    six months

Study Arms (2)

Smartphone Application

EXPERIMENTAL

Patients will be given access to a smartphone application for weight loss and instructed on how to use it.

Other: Smartphone Application

Usual primary care

NO INTERVENTION

Interventions

Smartphone ApplicationOTHER

Smartphone application to help monitor caloric intake and expenditure

Smartphone Application

Eligibility Criteria

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

You may qualify if:

  • primary care patient at UCLA Family Health Center or 16th Street Internal Medicine
  • age 18 or older,
  • English speaking,
  • BMI \> 25,
  • interested in losing weight,
  • smartphone ownership,
  • valid email address.

You may not qualify if:

  • current, planned or previous pregnancy within 6 months,
  • currently using a smartphone app for dieting,
  • hemodialysis,
  • terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Family Health Center

Santa Monica, California, 90404, United States

Location

UCLA Internal Medicine

Santa Monica, California, 90404, United States

Location

Related Publications (1)

  • Laing BY, Mangione CM, Tseng CH, Leng M, Vaisberg E, Mahida M, Bholat M, Glazier E, Morisky DE, Bell DS. Effectiveness of a smartphone application for weight loss compared with usual care in overweight primary care patients: a randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S5-12. doi: 10.7326/M13-3005.

    PMID: 25402403DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brian Y Laing, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Robert Wood Johnson Clinical Scholar

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 26, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(2)