Text Messaging for Weight Loss

Prediabetes Clinical Trial

Official title:

The Comparative Effectiveness of Clinic-Based Weight Loss Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063048
• Other study ID #: 13-1606 (Fischer)
• Secondary ID: 1R24HS022143-01
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: January 19, 2016
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Prediabetes
• Prediabetic State
• Weight Loss

Intervention

Behavioral:
• Text Message Based Weight Loss Support

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	Center for Health Systems Research at Denver Health, Colorado Health Outcomes Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute weight loss in pounds	Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.	12 months	No
Secondary	Percent weight loss	Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.	12 months	No
Secondary	Change in glycemic control as measured by HbA1c and fasting glucose		12 months	No
Secondary	Patient Engagement Measures	Response rate to text message prompts	12 months	No
Secondary	Percent of patients who maintain or lose weight	defined as weight gain less than two pounds	12 months	No
Secondary	Changes in systolic and diastolic blood pressure	based on usual care measurements	12 months	No
Secondary	Change in LDL-cholesterol	based on usual care measurements	12 months	No
Secondary	Operating costs per participant receiving intervention	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	No
Secondary	Patient Engagement Measures	Acceptability of the text-message based approach through individual interviews	12 months	No