NCT01171586|Completed
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Sponsor study identifier
NIH
interventional
318
1 country
1
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
July 26, 2010
Actual (reported)July 28, 2010
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)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
Intervention Effects
12 months
Weight Loss Between Intervention Arms
12 months
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 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UCSD, Atkinson Hall, 3rd Floor
La Jolla, California, 92037-0811, United States
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.
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.
Kevin Patrick, MD, MS
UCSD
318 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2010
First Posted
July 28, 2010
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
Intervention Satisfaction and Exposure
12 months
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.
Contact the study team to confirm eligibility.
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.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
December 5, 2014
Record last verified: 2014-12
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