NCT02063048

Brief Summary

The purpose of this study is to compare the effectiveness of text message-based support to usual care at promoting weight loss in patients with pre-diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

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

February 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

February 10, 2014

Last Update Submit

January 19, 2016

Conditions

Body WeightBody Weight ChangesPrediabetic StatePrediabetes

Keywords

weight lossText MessagingShort Message ServiceText Messages

Outcome Measures

Primary Outcomes (1)

  • Absolute weight loss in pounds

    Outcomes will be analyzed at baseline and at 6-month and 12-month follow-ups.

    12 months

Secondary Outcomes (8)

  • Percent weight loss

    12 months

  • Change in glycemic control as measured by HbA1c and fasting glucose

    12 months

  • Patient Engagement Measures

    12 months

  • Percent of patients who maintain or lose weight

    12 months

  • Changes in systolic and diastolic blood pressure

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Usual Care for Weight Loss

NO INTERVENTION

Patients randomized to this arm will not receive text messages or any other weight-loss support besides usual care provided at Denver Health. They will receive a weight loss educational packet and be asked to follow up with their primary care provider to further discuss their efforts at weight loss with additional follow-up as directed by their provider. They will be contacted periodically to be weighed. Providers will not be made aware that their patients are participating in the study's control arm.

Text Message Based Weight Loss Support

EXPERIMENTAL

Patients will receive the same weight loss educational packet as those randomized to usual care. Patients will be assisted in choosing a self-management goal related to exercise and to eating behaviors. They will receive text messages at a frequency up to 1x daily; input from focus groups will guide text message frequency.

Behavioral: Text Message Based Weight Loss Support

Interventions

Text Message Based Weight Loss SupportBEHAVIORAL
Text Message Based Weight Loss Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age or older
  • Ownership of a cell phone with SMS capabilities
  • HbA1c greater than 5.6 but less than 6.5
  • BMI ≥ 25 kg/m2 and less than 50 kg/m2
  • English or Spanish speakers.

You may not qualify if:

  • Individuals with co-morbid illness with life expectancy less than 12 months (e.g., terminal cancer, Child's Class C hepatic cirrhosis)
  • Diabetes based on an ICD-9 code in previous 3 years
  • Institutionalized individuals
  • Individuals not planning to stay in the area at least 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

Related Publications (2)

  • Fischer HH, Pereira RI, Moore SL, Durfee MJ, Rozwadowski JM, Havranek EP. Response to Comment on Fischer et al. Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. Diabetes Care 2016;39:1364-1370. Diabetes Care. 2016 Nov;39(11):e207-e208. doi: 10.2337/dci16-0024. No abstract available.

    PMID: 27926904DERIVED

  • Fischer HH, Fischer IP, Pereira RI, Furniss AL, Rozwadowski JM, Moore SL, Durfee MJ, Raghunath SG, Tsai AG, Havranek EP. Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. Diabetes Care. 2016 Aug;39(8):1364-70. doi: 10.2337/dc15-2137. Epub 2016 Feb 9.

    PMID: 26861922DERIVED

MeSH Terms

Conditions

Body WeightBody Weight ChangesPrediabetic StateWeight Loss

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Henry Fischer, MD

    Denver Health

    PRINCIPAL INVESTIGATOR

  • Edward Havranek, MD

    Denver Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician - Internal Medicine

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 14, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

US(1)