Text Messaging for Weight Loss

Obesity Clinical Trial

Official title:

Text Messaging for Weight Loss in Primary Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736111
• Other study ID #: HSC-MS-12-0571
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: November 9, 2015
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Overweight and obese adults recruited from the primary care setting (n=150) will be enrolled in a 6-month randomized trial of the INTERVENTION versus CONTROL. Both groups will receive usual medical care, printed materials, and educational text messages. The INTERVENTION group will also receive personalized coaching and feedback, as well as peer support, via text message.

The investigators hypothesize that compared to those in the Control group, patients in the Intervention group will lose more weight and demonstrate more favorable changes in fruit and vegetable intake, exercise, and social support for weight loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Approved to participate by PCP (Patients with diabetes, hypertension, or dyslipidemia will be eligible if approved by their PCP)

• Age = 21 years

• Body mass index (BMI) 25 to 45 kg/m2 and weight = 400 pounds

• Goal of losing weight (not just maintain weight)

• Willing to change diet, physical activity in order to lose weight.

• Currently uses text messaging in English on mobile phone

• Willing to use send and receive text messages for this study without direct compensation for cost of messages (general compensation for study participation will be provided)

• Have a scale at home for self-monitoring weight

• Fluent in English (speak, read, write)

• Commit to return for follow-up weight at 6 months regardless of amount of weight lost

Exclusion Criteria:

• Involuntary or voluntary weight loss of = 5% body weight in previous 6 months

• Participating in research project involving weight loss, exercise, or dietary modification in the previous 6 months

• Any of the following medical conditions which could affect weight or for which weight loss is contraindicated

• End-stage liver disease

• End-stage kidney disease

• Cancer within previous 2 years (except non-melanoma skin cancer)

• Myocardial infarction, stroke, or transient ischemic attack within previous 6 months

• Unstable angina

• Severe arthritis or other medical conditions which would prevent brisk walking

• Schizophrenia

• Hospitalization for psychiatric problems during the prior 12 months.

• Current use or anticipated future use (during 6 month study) of medications that could cause weight loss:

• phentermine

• orlistat (prescription Xenical or OTC Alli)

• topiramate

• buprioprion

• exenatide (Byetta)

• liraglutide (Victoza)

• Prior bariatric surgery or plans for bariatric surgery in next 6 months

• Pregnant or breast feeding within the previous 6 months

• Planning to become pregnant in next 6 months

• Consumes > 14 alcoholic drinks per week

• Current use of illicit drugs

• Planning to move out of the area in the next 6 months

• Another member of household or a close contact is participating in the study

Study Design

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• one way text

• Personal feedback

Locations

Country	Name	City	State
United States	UT Physicians - Internal Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from baseline	Weight in a lightweight hospital gown with no shoes (calibrated digital scale)	baseline and 6 months	No
Secondary	Change in diet measured by Fruit and Vegetable Screener (NCI)		baseline and 6 months	No
Secondary	Change in physical activity as measured by Paffenbarger physical activity questionnaire		baseline and 6 months	No
Secondary	Change in social support as measured by Weight Management Support Inventory	A validated questionnaire with 4 domains of social support for weight control (emotional, instrumental, informational, and appraisal)	baseline and 6 months	No
Secondary	Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)	Measures the individual's self-rated executive functioning.	baseline and 6 months	No