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

Study Overview
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Brief Summary
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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.

Detailed Description
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Hispanic women have the highest estimated lifetime risk of developing diabetes of all ethnic/gender groups in the US, and their prevalence rates of overweight and obesity are among the highest in the US. Currently, nearly 90% of Hispanic women aged 40-59 are overweight or obese. If diagnosed with Type 2 diabetes (T2D) at age 40, Hispanic women are projected to lose 12.4 life-years, and 21.5 quality-adjusted life-years. Several clinical trials have produced compelling evidence demonstrating the benefits of weight-loss interventions for both diabetic and pre-diabetic individuals, but most of the successful interventions tested in large clinical trials have been too costly for implementation in community settings, and they have not been assessed under real life conditions, targeting vulnerable populations. This study builds on the investigators' success with a culturally-tailored weight-loss intervention designed for Hispanic women. Elements of cultural adaptation will include: women-only groups, skill-building tasks around food measurement, focus on traditional dietary habits and cultural norms regulating food preparation and consumption, interactive learning formats with a minimum of written materials, culturally congruent physical activity, and addressing acculturative concerns. Follow-up data, including change in weight, waist circumference, and diabetes outcomes, will be collected at 6-, 12-, and 18-months post randomization. Additional analyses will include the cost of delivering the intervention and assessing the intervention's sustainability. The results of this study will inform the development of interventions to prevent diabetes onset or manage T2D in this population. Description of Measures Used Southwest Food Frequency Questionnaire (SWFFQ). The Southwestern Food Frequency Questionnaire (SWFFQ) consists of 158 food items and was adapted from the Arizona Food Frequency Questionnaire. It provides a culturally appropriate means of collecting dietary information for the Southwestern U.S. Hispanic populations predominantly of Mexican descent. It is the only Spanish bicultural and bilingual questionnaire in widespread use in the country. Examples of food items that are included in the questionnaire are nopalitos (cactus leaves), corn and flour tortillas, refried beans, machaca, and chorizo. The SWFFQ has been tested for validity and reliability (Taren et al, 2000). The output provides 87 nutrients in addition to 25 derived variables such as percent of calories from fat. VALIDATION PAPER Taren D, Tobar M, Ritenbaugh C, Graver E, Whitacre R, Aickin M. Evaluation of the Southwest Food Frequency Questionnaire. Ecology of Food and Nutrition 38:515-547, 2000. General Practice Physical Activity Questionnaire (GPPAQ) The GPPAQ is a validated screening tool for use in primary care that is used to assess adult (16 - 74 years) physical activity levels. It provides a simple, 4-level Physical Activity Index (PAI) categorizing patients as: Active, Moderately Active, Moderately Inactive, and Inactive. SOURCE: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/192453/GPPAQ_-_guidance.pdf Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a well-validated, 8-item Likert-type questionnaire that has been widely used in studies of physical and mental health among Spanish-speaking and Hispanic individuals. SOURCE http://www.csqscales.com/csq-8.htm Barriers to Healthy Eating Questionnaire (BHEQ) The BHE is a 22-item questionnaire asking individuals to rate various feelings or situations related to following the calorie and fat-restricted diet, eg, feelings of deprivation or cost of the recommended eating plan. It has 3 subscales: Emotions (11 items), Daily Mechanics of Following a Healthy Eating Plan (8 items), and Social Support (3 items). VALIDATION PAPER Impact of Perceived Barriers to Healthy Eating on Diet and Weight in a 24-Month Behavioral Weight Loss Trial. Wang, Jing et al. Journal of Nutrition Education and Behavior , Volume 47 , Issue 5 , 432 - 436.e1 Subjective Numeracy Scale The Subjective Numeracy Scale (SNS) is a self-report measure of perceived ability to perform various mathematical tasks and preferences for the use of numerical versus prose information. The SNS has been validated against objective numeracy measures and found to predict comprehension of risk communications and ability to complete utility elicitations. The De Por Vida study asked questions 3 and 4 of the SNS ability subscale which asked respondents to assess their numerical ability in different contexts. The scale contains no mathematics questions and has no correct or incorrect answers. VALIDATION PAPER Fagerlin, A., Zikmund-Fisher, B.J., Ubel, P.A., Jankovic, A., Derry, H.A., & Smith, D.M. Measuring numeracy without a math test: Development of the Subjective Numeracy Scale (SNS). Medical Decision Making, 2007: 27: 672-680. Screening Questions for Limited Health Literacy We asked 3 screening questions to assess limited health literacy validated by Chew et al. VALIDATION PAPER Chew LD, Griffin JM, Partin MR, et al. Validation of Screening Questions for Limited Health Literacy in a Large VA Outpatient Population. Journal of General Internal Medicine. 2008;23(5):561-566. doi:10.1007/s11606-008-0520-5. Language-Based Acculturation Scale A simple scale for quantifying English use among Mexican Americans was constructed from four brief questions which proved to have excellent scaling characteristics by Guttman Scalogram Analysis in two independent data sets. Construct validity was established by significant associations of the scale with ethnicity, place of birth, generation within the United States, and type of neighborhood. Highly significant associations were found between scale scores and use of oral contraceptives, parity, fatalism regarding health, and attitudes toward folk healers. These associations remained significant (though weak) after controlling for education and family income. The language scale thus appears to be reliable and valid, to be capable of distinguishing meaningful subsets among the Mexican American population, and to be applicable to health care investigation. VALIDATION PAPER A Simple Language-based Acculturation Scale for Mexican Americans: Validation and Application to Health Care Research. Deyo, Richard A.; And Others. American Journal of Public Health, v75 n1 p51-55 Jan 1985

Official Title
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Culturally Competent Behavioral Intervention for Diabetes Risk Reduction

Conditions
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Diabetes, Weight Loss, PreDiabetes, Obesity

Intervention / Treatment
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* Behavioral: Behavioural Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 2-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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Trial participants are randomly assigned to one of two conditions: 1) Enhanced usual care control, or 2) a culturally tailored behavioral intervention.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral<br>26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change | Behavioral: Behavioural Lifestyle Intervention<br>* A culturally tailored behavioral intervention.<br>|
| No Intervention: Enhanced usual care<br>Printed materials | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3) | Comparison of hemoglobin HbA1c trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the inverse cube, or 1/HbAlc%^3) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the inverse cube of HbA1c, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed HbA1c, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed HbA1c if it is of greater priority to have more direct interpretability of the HbA1c values than using the model that better meets the statistical assumptions. | Baseline, 6, 12 and 18 months from enrollment | 
| Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 ) | Comparison of fasting blood glucose trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the inverse square, or 1/fasting blood glucose in mg/dl^2) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the inverse square of fasting blood glucose, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed fasting blood glucose, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed fasting blood glucose if it is of greater priority to have more direct interpretability of the fasting blood glucose values than using the model that better meets the statistical assumptions. | Baseline, 6, 12, and 18 months | 
| Total Cholesterol | Comparison of total cholesterol trajectories between the intervention and usual-care control groups. | Baseline, 6, 12, and 18 months | 
| Number of Fruit Servings Per Day (Transformed Using the Natural Log) | Comparison of number fruit servings per day trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the number of fruit servings per day, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed number of fruit servings per day, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed number of fruit servings per day if it is of greater priority to have more direct interpretability of the # of fruit servings per day values than using the model that better meets the statistical assumptions. | Baseline, 6, 12, and 18 months | 
| Number of Kilocalories | Comparison of the number of kilocalories trajectories between the intervention and usual-care control groups. | Baseline, 6, 12, and 18 months | 
| Sugar Intake in Grams | Comparison of the sugar intake in grams trajectories between the intervention and usual-care control groups. | Baseline, 6, 12, and 18 months | 
| Dietary Fiber Intake in Grams (Transformed Using the Natural Log) | Comparison of the dietary fiber intake in grams trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the dietary fiber intake in grams and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed dietary fiber intake in grams, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed dietary fiber intake in grams if it is of greater priority to have more direct interpretability of the dietary fiber intake in grams values than using the model that better meets the statistical assumptions. | Baseline, 6, 12, and 18 months | 
| Saturated Fat Intake as Percentage of Total Energy Intake | Comparison of the saturated fat intake as percentage of total energy intake trajectories between the intervention and usual-care control groups. | Baseline, 6, 12, and 18 months | 
| Number of Vegetable Servings Per Day (Transformed Using the Natural Log) | Comparison of the dietary intake of the number of vegetable servings per day trajectories between the intervention and usual-care control groups. Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the number of vegetable servings per day, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed outcome, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed number of vegetable servings per day if it is of greater priority to have more direct interpretability of the outcome values than using the model that better meets the statistical assumptions. | Baseline, 6, 12, and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Culturally-tailored, Weight Loss, Diabetes, Women, Hispanic, Obesity