NCT01797510

Brief Summary

This study is designed to compare an intensive lifestyle and activity coaching program (\"Sessions\") to usual care for diabetic patients who are sedentary. The question to be answered is whether the Sessions program improves clinical or patient centric outcomes. Recruitment is through invitiation only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

February 20, 2013

Last Update Submit

August 1, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Biometrics

    BMI, Blood Pressure

    6 months

Study Arms (2)

Coaching

EXPERIMENTAL

Interventional web based coaching study

Behavioral: Web Based Health Coaching

Usual Care

NO INTERVENTION

Interventions

Web Based Health CoachingBEHAVIORAL
Coaching

Eligibility Criteria

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

You may qualify if:

  • Diabetic patients age 18 or greater

You may not qualify if:

  • Patients aged 17 or less,
  • Patients with cognition impaired such that they could not comprehend enrollment materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marc Matthews, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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
Assistant Professor, Department of Family Medicine

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

US(1)