Type 2 Diabetes
Conditions
Brief summary
The goal of this project is to use a two-stepped study to examine both the adoption of the three dietary patterns as presented by the United States Dietary Guidelines (USDG) and testing of a refined, culturally tailored one-year intervention examining the three diet patterns. For this study, African American adult participants with overweight/obesity and ≥three type 2 diabetes (T2DM) risk factors will be recruited to participate in this two-step study. This present study is for our Step 1: formative pilot work to culturally-tailor a dietary intervention of the three healthy eating patterns presented by the USDG for 12 weeks: 1) U.S.-Style, 2) Mediterranean, or 3) Vegetarian.
Detailed description
The U.S. Dietary Guidelines (USDG) form the basis of federal nutrition programs and policy and provide valuable guidance to health initiatives and industries. The updated 2015 USDG moved away from a focus on individual nutrients to a greater focus on dietary patterns. The USDG state that healthy eating goals can be met through a variety of dietary patterns, but present healthy diet in three main ways: 1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern. Currently, US adults are falling short of the nutrition recommendations (fruit/vegetable intake, greens/beans, whole grains, etc.) set forth by the USDG and measured by the Healthy Eating Index (HEI). While the USDG are the basis of nutrition guidelines, the research informing these dietary pattern recommendations has largely been drawn from observational studies among mostly white populations. In addition, there has been very limited cultural tailoring of these dietary patterns that would ensure that these diets are acceptable to diverse populations, in particular, African Americans (AAs) living in the south, who experience a disproportionate burden of chronic disease, especially type 2 diabetes (T2DM). Currently, US adults are not meeting nutrition recommendations (fruit/vegetable, whole grains, etc.) set forth by the USDG and measured by the Healthy Eating Index (HEI). For the present study, AA adult participants with overweight/obesity and ≥three T2DM risk factors will be recruited to participate in the following aims: Aim 1: Conduct a 3-month randomized trial among AAs comparing adoption of the 3 dietary patterns \[1) US, 2) Med, or 3) Veg\] using existing materials from the USDG and examine differences in diet quality (HEI) and T2DM risk factors (weight, HgbA1c). Aim 2: Drawing on participants' experiences in Aim 1, conduct qualitative work to refine and culturally tailor the dietary pattern intervention for an AA audience.
Interventions
BEHAVIORALDietary Intervention Meetings
Participants will attend classes once per week for 3 months.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be blinded to participant group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years of age * BMI between 25- 49.9 kg/m2 * self-identify as African American * live in the Columbia, SC area * be able to attend all monitoring visits * be willing to be randomized to either condition and be re-randomized if non-responsive * be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
Exclusion criteria
* should not be pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 24 months, or currently breastfeeding o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult with her healthcare provider and will be dropped from the weight loss study. * should be free of an eating disorder as screened by the Eating disorder Screen for Primary care \[ESP\]. (If a participant has an eating disorder, they will be given contact information for the eating disorder clinic at the University of South Carolina) * no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own) * no recent or planned bariatric surgery * no recent weight loss (\>10 lbs in the last 6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta Dietary Quality | From baseline to the end of the intervention at 3 months | Change in Healthy Eating Index (HEI) total score was calculated as 3-month follow-up score minus baseline score. HEI total scores range from 0 to 100, with higher scores indicating better diet quality and greater adherence to dietary guidelines. The change score could potentially range from -100 to +100. Positive change scores indicate improvement in diet quality, whereas negative change scores indicate worsening diet quality. HEI total scores were calculated from three averaged 24-hour dietary recalls collected at each time point using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA24). |
| Delta Body Weight | From baseline to the end of the intervention at 3 months | Change in body weight from baseline to the end of the intervention at 3 months |
| Delta Hemoglobin A1c | From baseline to the end of the intervention at 3 months | Change in HgbA1c from baseline to the end of the intervention at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delta Systolic Blood Pressure | From baseline to the end of the intervention at 3 months | Change in systolic blood pressure from baseline to the end of the intervention at 3 months |
| Delta Diastolic Blood Pressure | From baseline to the end of the intervention at 3 months | Change in diastolic blood pressure from baseline to the end of the intervention at 3 months |
Countries
United States
Participant flow
Recruitment details
The DG3D Aim 1 study was a 12-week, 3-arm randomized dietary intervention. Recruitment was implemented through news, media, and online/social media advertisements, electronic mailing lists, community outreach events, and flyers. Recruitment occurred from July - September 2021.
Pre-assignment details
Eligible and interested participants were offered a choice of orientation session times. During the session, the study coordinator provided a comprehensive overview of the study, addressed participant questions, and obtained informed consent. Those who successfully completed baseline procedures were subsequently randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.0 y STANDARD_DEVIATION 10.6 |
| Body Mass Index (BMI) | 35.7 kg/m2 STANDARD_DEVIATION 4.9 |
| Body weight | 101.6 kg STANDARD_DEVIATION 24.1 |
| Diastolic Blood Pressure | 80.4 mmHg STANDARD_DEVIATION 9 |
| Education Advanced degree | 26 Participants |
| Education College graduate | 9 Participants |
| Education Some college | 11 Participants |
| HbA1c | 5.9 % STANDARD_DEVIATION 0.3 |
| Healthy Eating Index (HEI) Score | 57.8 Scores on a scale STANDARD_DEVIATION 12.7 |
| Marital Status Divorced or separated | 2 Participants |
| Marital Status Married | 11 Participants |
| Marital Status Partnered/living with someone | 0 Participants |
| Marital Status Single | 17 Participants |
| Occupation Employed for wages | 37 Participants |
| Occupation No current employment | 2 Participants |
| Occupation Other | 1 Participants |
| Occupation Retired | 4 Participants |
| Race/Ethnicity, Customized Race Black | 22 Participants |
| Race/Ethnicity, Customized Race Black and other race | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
| Systolic Blood Pressure | 128.9 mmHg STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 | 0 / 20 |
| other Total, other adverse events | 0 / 21 | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 | 0 / 20 |
Outcome results
None listed