De Por Vida: A Diabetes Risk Reduction Intervention for Hispanic Women

NCT03113916 | Completed Results DMC

• 1 other identifier: 5R01DK099277-04
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. The intervention will be integrated into patient care at a Federally Qualified Health Center serving over 30,000 low-income patients, and will be delivered by trained clinic staff, with minimal support from research staff. After the effectiveness clinical trial, two cohorts of clinic patients will receive the intervention in a sustainability test.

Conditions

Diabetes; Weight Loss; PreDiabetes; Obesity

Keywords

Culturally-tailored; Weight Loss; Diabetes; Women; Hispanic; Obesity

Outcome Measures

Primary Outcomes (2)

• Weight in Kilograms

  Comparison of body weight trajectories in kilograms between the intervention and usual-care control groups.

  Baseline, 6, 12, and 18 months

• Waist Circumference in Centimeters

  Comparison of waist circumference trajectories in centimeters between the intervention and usual-care control groups.

  Baseline, 6, 12, and 18 months

Secondary Outcomes (9)

• Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)

  Baseline, 6, 12 and 18 months from enrollment

• Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )

  Baseline, 6, 12, and 18 months

• Total Cholesterol

  Baseline, 6, 12, and 18 months

• Number of Fruit Servings Per Day (Transformed Using the Natural Log)

  Baseline, 6, 12, and 18 months

• Number of Kilocalories

  Baseline, 6, 12, and 18 months

Other Outcomes (2)

• Average Program Cost Per Participant

  12 months

• Recruit Participants for Sustainability Phase

  Post-intervention for 12 months

Study Arms (2)

Behavioral

EXPERIMENTAL

26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change

Behavioral: Behavioural Lifestyle Intervention

Enhanced usual care

NO INTERVENTION

Printed materials

Interventions

Behavioural Lifestyle Intervention BEHAVIORAL

A culturally tailored behavioral intervention.

Behavioral

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be patients who receive their primary medical care at the Virginia Garcia Memorial Health Center (VGMHC)
• Self-identified as Spanish-speaking Latina or Hispanic
• Female
• Age 18 and older
• BMI greater than or equal to 27kg/m2
• Classified as diabetic or prediabetic in the electronic medical record by at least one of the following:
• Fasting plasma glucose ≥ 100
• h post glucose level on the 75-g oral glucose tolerance test ≥ 140-199 mg/dL (7.8-11.0 mmol/L)
• Hemoglobin HBA1c ≥ 5.7
• Diagnosis of diabetes in patient's medical chart
• Diagnosis of prediabetes in patient's medical chart
• Residing in the Portland metropolitan area, and having no plans to leave the area in the next 18 months.
• Willing and able to attend the 26-weekly group meetings and 6 monthly group meetings.
• Willing to accept random assignment to the active intervention or enhanced usual care control.
• Clearance by the patient's VGMHC primary care physician to participate in the intervention.

You may not qualify if:

• Treatment for cancer in the past two years (excluding non-melanoma skin cancers).
• Having conditions that require limitation of physical activity or that would be contraindicated for the DASH (Dietary Approaches to Stop Hypertension) diet patterns.
• Taking weight-loss medication currently or within the past 6 months.
• Current or recent (\< 12 months) pregnancy, breastfeeding, or planning pregnancy in the next 18 months.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Arizona State University: collaborator

Related Publications (1)

• Lindberg NM, Vega-Lopez S, LeBlanc ES, Leo MC, Stevens VJ, Gille S, Arias-Gastelum M, Meenan R. Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic. Front Endocrinol (Lausanne). 2021 Jan 8;11:489882. doi: 10.3389/fendo.2020.489882. eCollection 2020.

  PMID: 33488511 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Weight Loss; Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders

Results Point of Contact

• Title: Nangel Lindberg
• Organization: Kaiser Permanente Center for Health Research

Nangel.M.Lindberg@kpchr.org

503 528 3961

Study Officials

• Nangel Lindberg, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Trial participants are randomly assigned to one of two conditions: 1) Enhanced usual care control, or 2) a culturally tailored behavioral intervention.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: June 23, 2014
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: September 23, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share