Primary Care-Based Physical Activity for Diabetic Latinas

NCT02741050 | Terminated

• 1 other identifier: K01DK101650
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes. The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months. The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.

Conditions

Diabetes; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (2)

• Objective Changes in Physical Activity from Baseline to 6 Months

  The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months.

  Baseline, 6 Months (MO)

• Self-Report Changes in Physical Activity from Baseline to 6 Months

  The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from baseline to 6 months. The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities. The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.

  Baseline, 6 Months (MO)

Secondary Outcomes (2)

• Objective Changes in Physical Activity from 6 Months to 12 Months

  6 Months (MO), 12 Months (MO)

• Self-Report Changes in Physical Activity from 6 Months to 12 Months

  6 Months (MO), 12 Months (MO)

Study Arms (2)

Tailored Physical Activity Intervention

EXPERIMENTAL

Intervention group will receive Spanish-language physical activity print intervention based on SCT and Transtheoretical Model, (TTM) that emphasizes behavioral strategies for increasing activity levels.

Behavioral: Tailored Physical Activity Intervention

Standard of Care Control Group

ACTIVE COMPARATOR

Control group will receive standard of care through the Family Medicine clinic as well as monthly questionnaires on topics other than physical activity (e.g. diet) to complete.

Behavioral: Standard of Care

Interventions

Tailored Physical Activity Intervention BEHAVIORAL

The Tailored Internet intervention is based on constructs of the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT). During the 6-month intervention period, participants will receive monthly mailed questionnaires that assess current motivational readiness for physical activity and other TTM and SCT constructs (e.g., process of change, self-efficacy) and monthly logs to record their current activity.

Also known as: Camino a La Salud

Tailored Physical Activity Intervention

Standard of Care BEHAVIORAL

Those assigned to the control group will continue to receive standard of care through the Family Medicine clinic. This currently entails commonly accepted medication treatment strategies, educational materials and counseling for self-management and medication adherence, screening for depression or other conditions that would impair self-management, and national and state quality of care guidelines for lab testing and control targets (HbA1c, lipids, blood pressure). Participants in the control group will also receive monthly questionnaires on topics other than physical activity (e.g. diet) to fill out and return in order to have the same opportunities for compensation as those in the intervention condition.

Standard of Care Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have received a physician's diagnosis of type II diabetes and are currently being seen by a primary care physician
• Currently inactive, defined as participating in at least moderate intensity physical activity for less than 60 minutes per week

You may not qualify if:

• Medical condition that may make exercise unsafe, including congestive heart failure, severe musculoskeletal problems or pulmonary conditions, or other conditions determined by the referring physician to preclude unsupervised exercise
• Unable to receive mailed materials (do not have a mailing address)
• Unable to engage in physical activity for at least 30 minutes
• Have a current or planned pregnancy
• Planning to move from the area within the next year

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093-0628, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Sedentary Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Britta Larsen, PhD

  UC, San Diego Department of Family Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Family Medicine and Public Health

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 18, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)