NCT01171586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

4.1 years

First QC Date

July 26, 2010

Last Update Submit

December 3, 2014

Conditions

OverweightWeight Loss

Keywords

Obesityoverweightweight lossweight maintenanceSMStechnologycell phonephysical activitynutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (3)

  • Intervention Effects

    12 months

  • Weight Loss Between Intervention Arms

    12 months

  • Intervention Satisfaction and Exposure

    12 months

Study Arms (3)

SMS Only

EXPERIMENTAL

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.

Behavioral: mDiet

SMS + Phone Counseling

EXPERIMENTAL

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.

Behavioral: mDiet

Control

NO INTERVENTION

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.

Interventions

mDietBEHAVIORAL

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.

SMS + Phone CounselingSMS Only

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD, Atkinson Hall, 3rd Floor

La Jolla, California, 92037-0811, United States

Location

Related Publications (3)

  • 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.

    PMID: 31553725DERIVED

  • 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.

    PMID: 24670075DERIVED

  • 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.

    PMID: 24200517DERIVED

MeSH Terms

Conditions

OverweightWeight LossObesityMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Study Officials

  • Kevin Patrick, MD, MS

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 28, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

US(1)