Text Messaging for Weight Loss

January 19, 2016 updated by: Henry Fischer, Denver Health and Hospital Authority

The Comparative Effectiveness of Clinic-Based Weight Loss Strategies

The purpose of this study is to compare the effectiveness of text message-based support to usual care at promoting weight loss in patients with pre-diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Text messaging has been shown to be effective for weight-loss in very limited testing. DH has experience with both text message based intervention and weight management intervention. This study aims to enhance Denver Health's (DH) existing Patient Relationship Management (PRM) text message (SMS) infrastructure to include culturally-appropriate outreach to promote weight loss.

Subjects will be randomized into one of two arms:

  • Usual care: Patients randomized to this arm will not receive text messages or any other weight-loss support besides usual care provided at DH. They will receive a weight loss educational packet and be asked to follow up with their primary care provider to further discuss their efforts at weight loss with additional follow-up as directed by their provider. They will be contacted periodically to be weighed. Providers will not be made aware that their patients are participating in the study's control arm.
  • Text Message-based weight loss support. Patients will receive the same weight loss educational packet as those randomized to usual care. Patients will be assisted in choosing a self-management goal related to exercise and to eating behaviors. They will receive text messages at a frequency up to 1x daily; input from focus groups will guide text message frequency.

SMS content is similar to the Diabetes Prevention Program (DPP) curriculum and will fall into the following categories:

  • Outgoing "tips of the day"
  • Interactive messages that solicit a simple response for the day from the participant
  • Outgoing reminders to inform participant about events in the community and about clinic appointments with their primary care provider.

Basic descriptive statistics for categorical variables will be generated to describe the baseline demographic and clinical characteristics. Univariate analyses will be performed to determine whether there are differences between patients in the three arms of the intervention. For clinical outcomes, general linear mixed effects models will be used with intervention and time (and their interactions) specified as fixed effects to determine whether change over time in outcomes differs significantly for the three groups. A random subject effect will be specified to model the correlation of observations taken on an individual. Contrasts will be constructed to test the difference in interventions at six months and 12 months. If the data do not follow an approximate normal distribution or cannot be normalized using log transformation the ranks of the outcomes will be analyzed in the mixed effects model. All statistical analyses will be performed using Statistical Analysis Software (SAS) version 9.2.

The study is powered to detect a difference at six months between the text message group and the usual care group. Previous research suggests that, with 60 participants per group, researchers would have 89% power to detect a difference between groups of 1.7 kg. The investigators think that this is a reasonable estimate, as subjects in the control group in this study lost 0.4 kg, and it is believed that subjects in the control group will be weight stable. While investigators anticipate that patients who participate in the DPP program will lose weight, it is believed participation across the usual care and SMS groups will be comparable as i) randomization is stratified to the two groups by past participation in the DPP and ii) relatively equal participation in the two groups is anticipated throughout the intervention period. This stratification is intended to equalize the effects of class-attendance heterogeneity across the two study groups. The study aims to have 90 participants per group to improve the power for sub-group analyses.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years of age or older
  • Ownership of a cell phone with SMS capabilities
  • HbA1c greater than 5.6 but less than 6.5
  • BMI ≥ 25 kg/m2 and less than 50 kg/m2
  • English or Spanish speakers.

Exclusion Criteria:

  • Individuals with co-morbid illness with life expectancy less than 12 months (e.g., terminal cancer, Child's Class C hepatic cirrhosis)
  • Diabetes based on an ICD-9 code in previous 3 years
  • Institutionalized individuals
  • Individuals not planning to stay in the area at least 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care for Weight Loss
Patients randomized to this arm will not receive text messages or any other weight-loss support besides usual care provided at Denver Health. They will receive a weight loss educational packet and be asked to follow up with their primary care provider to further discuss their efforts at weight loss with additional follow-up as directed by their provider. They will be contacted periodically to be weighed. Providers will not be made aware that their patients are participating in the study's control arm.
Experimental: Text Message Based Weight Loss Support
Patients will receive the same weight loss educational packet as those randomized to usual care. Patients will be assisted in choosing a self-management goal related to exercise and to eating behaviors. They will receive text messages at a frequency up to 1x daily; input from focus groups will guide text message frequency.
Behavioral: Text Message Based Weight Loss Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute weight loss in pounds
Time Frame: 12 months
Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent weight loss
Time Frame: 12 months
Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.
12 months
Change in glycemic control as measured by HbA1c and fasting glucose
Time Frame: 12 months
12 months
Patient Engagement Measures
Time Frame: 12 months
Response rate to text message prompts
12 months
Percent of patients who maintain or lose weight
Time Frame: 12 months
defined as weight gain less than two pounds
12 months
Changes in systolic and diastolic blood pressure
Time Frame: 12 months
based on usual care measurements
12 months
Change in LDL-cholesterol
Time Frame: 12 months
based on usual care measurements
12 months
Operating costs per participant receiving intervention
Time Frame: 12 months
Costs from the perspective of the health system, including all personnel costs and technology costs, will be calculated. The upper 2.5% of the cost distribution curve will be truncated to eliminate outliers that would artificially skew results and use non-parametric methods if the distribution is non-normal as expected. The effect of scaling the intervention up two-fold and five-fold will undergo sensitivity analyses.
12 months
Patient Engagement Measures
Time Frame: 12 months
Acceptability of the text-message based approach through individual interviews
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Collaborators

Center for Health Systems Research at Denver Health
Colorado Health Outcomes Program

Investigators

  • Principal Investigator: Henry Fischer, MD, Denver Health
  • Study Director: Edward Havranek, MD, Denver Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 13, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1606 (Fischer)
  • 1R24HS022143-01 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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