NCT00415870

Brief Summary

This is a NCI funded study which will develop and evaluate a cell phone application (mDIET) that can be used as an assessment and intervention tool to improve dietary behaviors and thus reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration 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

First Submitted

Initial submission to the registry

December 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

September 4, 2013

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

December 22, 2006

Results QC Date

June 20, 2013

Last Update Submit

April 18, 2019

Conditions

Overweight

Keywords

OverweightCell PhoneTechnology

Outcome Measures

Primary Outcomes (1)

  • Mean Weight (kg)

    4 months

Secondary Outcomes (2)

  • Program Satisfaction

    4 months

  • Compliance With Food Monitoring Activities

    4 months

Study Arms (2)

PACE

EXPERIMENTAL

Received text messages and counseling calls

Behavioral: Printed MaterialBehavioral: Weekly WeighingBehavioral: Cell phone will serve as a self monitoring deviceDevice: Text MessageBehavioral: Diet Goals via Cell PhoneBehavioral: Food Monitoring

Control

NO INTERVENTION

Interventions

Printed MaterialBEHAVIORAL

Printed Material

PACE
Weekly WeighingBEHAVIORAL

Weekly Weighing

PACE
Cell phone will serve as a self monitoring deviceBEHAVIORAL

Cell phone will serve as a self monitoring device

PACE
Text MessageDEVICE

Text Message

PACE
Diet Goals via Cell PhoneBEHAVIORAL

Diet Goals via Cell Phone

PACE
Food MonitoringBEHAVIORAL

Food Monitoring

PACE

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be included if they:
  • Are age 25-55
  • Are overweight or moderately obese
  • Are with a BMI between 25.0-34.9 (as defined by the NIH report on Obesity (NIH 1998)
  • Are able to read (completion of at least the 6th grade) and speak English
  • Provide consent
  • Do not intend to become pregnant or move out of the county for the duration of the intervention (16 weeks).
  • Participants will also be required to have a cell phone that is capable of supporting the mDIET application.
  • Participants may be otherwise healthy or have one or more risk factors for CVD, including uncomplicated Type 2 diabetes but will not be enrolled if they have diagnosed CVD.

You may not qualify if:

  • Participants will be excluded from the study if they have any of the following conditions:
  • An eating disorder
  • Are currently pregnant
  • Have a strict dietary regimen prescribed by their doctor that will not allow them to comply with intervention guidelines related to dietary changes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Professional Suites

La Jolla, California, 92037, United States

Location

Related Publications (2)

  • Norman GJ, Kolodziejczyk JK, Adams MA, Patrick K, Marshall SJ. Fruit and vegetable intake and eating behaviors mediate the effect of a randomized text-message based weight loss program. Prev Med. 2013 Jan;56(1):3-7. doi: 10.1016/j.ypmed.2012.10.012. Epub 2012 Oct 22.

    PMID: 23085329DERIVED

  • Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100.

    PMID: 19141433DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Project Coordinator
Organization
UCSD
ldillon@ucsd.edu
858-534-9329

Study Officials

  • Kevin Patrick, MD, MS

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Professor

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

June 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 30, 2019

Results First Posted

September 4, 2013

Record last verified: 2019-04

Locations

US(1)