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Text Messaging for Weight Loss

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ClinicalTrials.gov Identifier: NCT02063048
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : January 21, 2016
Sponsor:
Collaborators:
Center for Health Systems Research at Denver Health
Colorado Health Outcomes Program
Information provided by (Responsible Party):
Henry Fischer, Denver Health and Hospital Authority

Brief 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.

Condition or disease Intervention/treatment Phase
Body Weight Body Weight Changes Prediabetic State Prediabetes Behavioral: Text Message Based Weight Loss Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Comparative Effectiveness of Clinic-Based Weight Loss Strategies
Study Start Date : April 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Absolute weight loss in pounds [ Time Frame: 12 months ]
    Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.


Secondary Outcome Measures :
  1. Percent weight loss [ Time Frame: 12 months ]
    Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.

  2. Change in glycemic control as measured by HbA1c and fasting glucose [ Time Frame: 12 months ]
  3. Patient Engagement Measures [ Time Frame: 12 months ]
    Response rate to text message prompts

  4. Percent of patients who maintain or lose weight [ Time Frame: 12 months ]
    defined as weight gain less than two pounds

  5. Changes in systolic and diastolic blood pressure [ Time Frame: 12 months ]
    based on usual care measurements

  6. Change in LDL-cholesterol [ Time Frame: 12 months ]
    based on usual care measurements

  7. 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.

  8. Patient Engagement Measures [ Time Frame: 12 months ]
    Acceptability of the text-message based approach through individual interviews



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063048


Locations
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United States, Colorado
Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
Center for Health Systems Research at Denver Health
Colorado Health Outcomes Program
Investigators
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Principal Investigator: Henry Fischer, MD Denver Health
Study Director: Edward Havranek, MD Denver Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henry Fischer, Physician - Internal Medicine, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02063048    
Other Study ID Numbers: 13-1606 (Fischer)
1R24HS022143-01 ( U.S. AHRQ Grant/Contract )
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by Henry Fischer, Denver Health and Hospital Authority:
weight loss
Text Messaging
Short Message Service
Text Messages
Additional relevant MeSH terms:
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Prediabetic State
Body Weight
Weight Loss
Body Weight Changes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases