NCT01571258

Brief Summary

The purpose of the present RCT is to evaluate a 12-month SMS intervention with expanded content, intervention strategies and interactive database logic, novel online enrollment, and automatic baseline scoring of measures to support a 12 month weight loss SMS intervention. The investigators hypothesized that the intervention group would have greater weight loss at 6 and 12 months than the control group and increased adherence to SMS would be associated with greater weight loss at 6 and 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
Last Updated

April 5, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

April 3, 2012

Last Update Submit

April 4, 2012

Conditions

Keywords

SMSObesityText MessagingInterventionMobile Phone

Outcome Measures

Primary Outcomes (1)

  • Weight

    We will assess the difference in weight loss between the intervention and the control group at 6 months and 12 months.

    6 months, 12 months

Secondary Outcomes (3)

  • Pedometer Steps/Day

    6 months, 12 months

  • Adherence

    6 months, 12 months

  • Treatment Satisfaction

    6 months and 12 months

Study Arms (2)

Control

NO INTERVENTION

Text Messaging

EXPERIMENTAL

Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.

Behavioral: Text Messaging

Interventions

Text MessagingBEHAVIORAL

Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.

Text Messaging

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 21 to 65 years
  • overweight or obese status: BMI between 25.0 and 39.9
  • regular access to the Internet
  • own and regularly use a cell phone and know how to use SMS
  • ability to read and speak English
  • ability to participate in moderate PA.

You may not qualify if:

  • current pregnancy or the intention of becoming pregnant during the 12 month trial
  • moving out of the country during the 12 month trial
  • current eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santech, Inc.

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Shapiro, PhD

    Santech, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Director

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

September 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 5, 2012

Record last verified: 2012-04

Locations