NCT01579292

Brief Summary

The goals of the study are to:

  1. 1.Assess effect sizes of our mDPP intervention on weight loss, physical activity, dietary intake, and fasting plasma glucose (FPG) levels from baseline to 5 months as compared to a control group.
  2. 2.To explore the association between low heath-literacy levels at baseline and adherence to mobile phone usage.
  3. 3.To conduct process evaluation to gain insights into patient compliance to the mobile intervention, including usage barriers and acceptability of our mDPP, at 1 and 5 months using a semi-structured interview method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

April 15, 2012

Last Update Submit

July 16, 2014

Conditions

Sedentary LifestylePhysical ActivityPre-Diabetic

Outcome Measures

Primary Outcomes (2)

  • Body weight (kg)

    5 months

  • Body mass index

    5 months

Secondary Outcomes (4)

  • Physical activity measured by Omron Active Style Pro HJA-350IT pedometer

    5 months

  • Total daily calories (kcal)

    5 months

  • Daily calories from fat (kcal)

    5 months

  • Fasting plasma glucose

    5 months

Study Arms (2)

Physical Activity and Diet Intervention

EXPERIMENTAL

5-month physical activity and diet intervention which includes 6 in-person sessions, mobile app, and pedometer

Behavioral: Mobile phone based physical activity with intervention

Pedometer only

ACTIVE COMPARATOR

Pedometer only

Behavioral: Pedometer Only

Interventions

Mobile phone based physical activity with interventionBEHAVIORAL

This group will receive a mobile phone software program and a pedometer. Over a 5-month period, participants in this group will be asked to participate in 6 in-person sessions, wear a pedometer, use a mobile phone physical activity and diet diary, and respond to daily physical activity and diet messages or video clips.

Physical Activity and Diet Intervention
Pedometer OnlyBEHAVIORAL

This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.

Pedometer only

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary lifestyle at work and/or during leisure time
  • Intend to be physically active
  • Are over 25 years of age
  • Access to a home telephone or a mobile phone
  • Speak and read English
  • Are not physically active
  • Have no disabilities that limit physical activity
  • Have high blood sugar (fasting blood sugar 100-125) but do not have diabetes

You may not qualify if:

  • Known medical conditions or other physical problems that need special attention in an exercise program
  • Plan a trip abroad during the first 5 months of the study period.
  • Pregnant/Delivered a baby during the last 6 months
  • Known severe hearing or speech problem
  • Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study
  • History of gastric bypass surgery or future plans for gastric bypass surgery in the next 5 months
  • Already taking medication for diabetes
  • Recovery from addiction
  • Known eating disorders
  • Bmi over 25 if non-Asian or over 23 if Asian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivityGlucose Intolerance

Interventions

Methods

Condition Hierarchy (Ancestors)

BehaviorHyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yoshimi Fukuoka, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2012

First Posted

April 17, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

US(1)