Text Messaging for Weight Loss

NCT01736111 | Completed DMC

• 1 other identifier: HSC-MS-12-0571
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; weight loss; text message

Outcome Measures

Primary Outcomes (1)

• Change in weight from baseline

  Weight in a lightweight hospital gown with no shoes (calibrated digital scale)

  baseline and 6 months

Secondary Outcomes (4)

• Change in diet measured by Fruit and Vegetable Screener (NCI)

  baseline and 6 months

• Change in physical activity as measured by Paffenbarger physical activity questionnaire

  baseline and 6 months

• Change in social support as measured by Weight Management Support Inventory

  baseline and 6 months

• Change in executive function as measured by Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)

  baseline and 6 months

Study Arms (2)

Personal feedback

EXPERIMENTAL

This arm will receive all intervention components of Active Comparator group, plus the following: 1. Text messages to prompt participant to reply with self-monitoring entries 2. Human coach uses system to send personalized text messages with feedback on self-monitoring entries

Behavioral: Personal feedback

One Way Text

ACTIVE COMPARATOR

1. Printed handouts from the "Aim for a Healthy Weight" booklet, which is published by National Heart, Lung, and Blood Institute and is frequently included in control conditions in primary care-based weight loss studies. Other handouts will discuss the use of prepackaged foods as well as setting goals for calorie intake, physical activity, and weight loss. 2. One to three text messages per week, based on topics from "Aim for a Healthy Weight" and other sources. The text messages will be pre-scheduled, automated, non-tailored, and "one-way" (no reply will be requested). The total dose of contact will be low because each text message is limited to 160 characters. The condition is comparable in intensity to control conditions in other weight loss trials in the primary care setting. 3. Usual medical care from the PCP. 4. Education on symptoms of hypoglycemia, hypotension, and cardiovascular disease, with instructions to contact their PCP in the event of those symptoms.

Behavioral: one way text

Interventions

one way text BEHAVIORAL

One Way Text

Personal feedback BEHAVIORAL

Personal feedback

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT Physicians - Internal Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Kevin O. Hwang, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Internal Medicine

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

US (1)