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mDiet: A Text Message Intervention for Weight Loss

Primary Purpose

Overweight, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mDiet
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Obesity, overweight, weight loss, weight maintenance, SMS, technology, cell phone, physical activity, nutrition

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are 21 - 60 years
  • Are overweight or moderately obese with a BMI between 27.0 - 39.9
  • Have a cell phone that is capable of sending and receiving text and picture messages
  • Have a permanent residence in San Diego County and intend to stay over the entire study duration
  • Speak and read English or Spanish
  • Are willing to attend all (3) measurement assessments at the research office
  • Provide assent and have a legal guardian that will participate and provide parental permission/consent

Exclusion Criteria:

  • Have any of the following conditions: pulmonary, cardiovascular, or musculoskeletal problems that would limit the ability to comply with moderate intensity physical activity (i.e. brisk walking)
  • Are pregnant or intend to become pregnant during the study period
  • Have a history of substance abuse
  • Have a psychiatric disorder that would impair compliance with the study protocol
  • Are using weight loss medications or supplements
  • Are currently involved in another weight loss study or program

Sites / Locations

  • UCSD, Atkinson Hall, 3rd Floor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

SMS Only

SMS + Phone Counseling

Control

Arm Description

The SMS only group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be "pushed" to participants (i.e. no response needed) and "pulled" from participants (i.e. response is needed). The SMS only group will also receive a brief printed or web based outline on weight loss resources and information.

This group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be "pushed" to participants (i.e. no response needed) and "pulled" from participants (i.e. response is needed). The group will also receive monthly counseling calls from a Health Coach to discuss barriers and solutions and will receive a brief printed or web based outline on weight loss resources and information.

The Control group will receive a binder with an attractive set of Standard Print Materials related to weight loss that is comparable to what one would receive from community resources such as libraries, magazines and national non-profit or governmental organizations such as 5-A Day, American Heart Association and the like.

Outcomes

Primary Outcome Measures

Weight Loss
To evaluate differences from baseline in percent weight loss at 12 months. We hypothesize that, compared to the usual care Standard Print condition differences in weight loss will be significant in both the SMS only (SMS = short message service or text message) and SMS+Phone intervention groups.

Secondary Outcome Measures

Intervention Effects
To assess the intervention effects on weight loss by study group, diet, physical activity and sedentary behaviors, quality of life, and depression
Weight Loss Between Intervention Arms
To assess differences in weight loss between the 2 intervention arms (SMS only and SMS plus phone counseling)
Intervention Satisfaction and Exposure
To assess the level of satisfaction and use of the intervention components (SMS, phone counseling)

Full Information

First Posted
July 26, 2010
Last Updated
December 3, 2014
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01171586
Brief Title
mDiet: A Text Message Intervention for Weight Loss
Official Title
mDiet: A Text Message Intervention for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the National Cancer Institute (NCI) funded randomized controlled study is to develop and evaluate a text message (SMS) based weight loss intervention to 309 overweight or moderately obese English and Spanish speaking adults ages 21 - 60. The investigators propose that participants randomized to the intervention arms will lose significantly more weight than those participants randomized to the control group.
Detailed Description
The SMS based intervention will be developed through formative research including focus groups, cognitive interviews, and a pilot test of a Spanish version of mDIET. The focus groups will be conducted with both English and Spanish speaking men and women to 1) learn more about the content areas to be addressed in the intervention including physical activity and sedentary behaviors to expand on previous research; 2) learn more about assessing equivalence and compatibility in intervention messages in English and Spanish; 3) identify the most culturally and linguistically appropriate messages; 4) assess text message use; 5) identify factors that influence food and physical activity decisions; and 6) identify health messages that Latinos see as most understandable, credible, and persuasive, cognitive interviews, and a pilot test of a Spanish version of mDIET. The cognitive interviews will be conducted in Spanish and will help inform translation of study materials (text messages and measures) from English to Spanish. An 8-week pilot test of the Latino (Spanish language) mDIET will be conducted to ensure that the text messages and SMS system works as expected in terms of usability and acceptability. The randomized controlled trial will be a 12-month intervention with 309 study participants. Participants will be randomized to one of three groups: SMS-only, SMS plus phone counseling, and a control group (Details of the study arms are discussed in another section). The goals of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss, 500 k/cal per day deficit through reduced caloric intake and increased energy expenditure, 12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors. Participants will receive daily text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics. Participants will complete physiological and survey measures at baseline, 6 months, and 12 months to assess weight (BMI), physical activity and diet behaviors, psychosocial behaviors, environmental factors, and exposure and satisfaction with the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Weight Loss
Keywords
Obesity, overweight, weight loss, weight maintenance, SMS, technology, cell phone, physical activity, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS Only
Arm Type
Experimental
Arm Description
The SMS only group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be "pushed" to participants (i.e. no response needed) and "pulled" from participants (i.e. response is needed). The SMS only group will also receive a brief printed or web based outline on weight loss resources and information.
Arm Title
SMS + Phone Counseling
Arm Type
Experimental
Arm Description
This group will receive hints, tips, strategies, and questions related to weight loss behaviors, physical activity, nutrition, and motivation. The messages will be "pushed" to participants (i.e. no response needed) and "pulled" from participants (i.e. response is needed). The group will also receive monthly counseling calls from a Health Coach to discuss barriers and solutions and will receive a brief printed or web based outline on weight loss resources and information.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control group will receive a binder with an attractive set of Standard Print Materials related to weight loss that is comparable to what one would receive from community resources such as libraries, magazines and national non-profit or governmental organizations such as 5-A Day, American Heart Association and the like.
Intervention Type
Behavioral
Intervention Name(s)
mDiet
Intervention Description
The goals of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss, 500 k/cal per day deficit through reduced caloric intake and increased energy expenditure, 12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors. Participants will receive daily "pushed" and "pulled" text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics.
Primary Outcome Measure Information:
Title
Weight Loss
Description
To evaluate differences from baseline in percent weight loss at 12 months. We hypothesize that, compared to the usual care Standard Print condition differences in weight loss will be significant in both the SMS only (SMS = short message service or text message) and SMS+Phone intervention groups.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Intervention Effects
Description
To assess the intervention effects on weight loss by study group, diet, physical activity and sedentary behaviors, quality of life, and depression
Time Frame
12 months
Title
Weight Loss Between Intervention Arms
Description
To assess differences in weight loss between the 2 intervention arms (SMS only and SMS plus phone counseling)
Time Frame
12 months
Title
Intervention Satisfaction and Exposure
Description
To assess the level of satisfaction and use of the intervention components (SMS, phone counseling)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are 21 - 60 years Are overweight or moderately obese with a BMI between 27.0 - 39.9 Have a cell phone that is capable of sending and receiving text and picture messages Have a permanent residence in San Diego County and intend to stay over the entire study duration Speak and read English or Spanish Are willing to attend all (3) measurement assessments at the research office Provide assent and have a legal guardian that will participate and provide parental permission/consent Exclusion Criteria: Have any of the following conditions: pulmonary, cardiovascular, or musculoskeletal problems that would limit the ability to comply with moderate intensity physical activity (i.e. brisk walking) Are pregnant or intend to become pregnant during the study period Have a history of substance abuse Have a psychiatric disorder that would impair compliance with the study protocol Are using weight loss medications or supplements Are currently involved in another weight loss study or program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Patrick, MD, MS
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD, Atkinson Hall, 3rd Floor
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0811
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31553725
Citation
Godino JG, Golaszewski NM, Norman GJ, Rock CL, Griswold WG, Arredondo E, Marshall S, Kolodziejczyk J, Dillon L, Raab F, Jain S, Crawford M, Merchant G, Patrick K. Text messaging and brief phone calls for weight loss in overweight and obese English- and Spanish-speaking adults: A 1-year, parallel-group, randomized controlled trial. PLoS Med. 2019 Sep 25;16(9):e1002917. doi: 10.1371/journal.pmed.1002917. eCollection 2019 Sep.
Results Reference
derived
PubMed Identifier
24670075
Citation
Kolodziejczyk JK, Norman GJ, Roesch SC, Rock CL, Arredondo EM, Madanat H, Patrick K. Exploratory and confirmatory factor analyses and demographic correlate models of the strategies for weight management measure for overweight or obese adults. Am J Health Promot. 2015 Mar-Apr;29(4):e147-57. doi: 10.4278/ajhp.130731-QUAN-391. Epub 2014 Mar 26.
Results Reference
derived
PubMed Identifier
24200517
Citation
Kolodziejczyk JK, Norman GJ, Barrera-Ng A, Dillon L, Marshall S, Arredondo E, Rock CL, Raab F, Griswold WG, Sullivan M, Patrick K. Feasibility and effectiveness of an automated bilingual text message intervention for weight loss: pilot study. JMIR Res Protoc. 2013 Nov 6;2(2):e48. doi: 10.2196/resprot.2789.
Results Reference
derived

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mDiet: A Text Message Intervention for Weight Loss

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