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This study will address the following aims:
Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring (6-17 years).
Aim 2: Test the feasibility, acceptability, enrollment, retention, and completion rates of a 2-week family-centered whole foods-based diet for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring 6-17 years.
Aim 3: Estimate and compare differences in baseline and 2-week body mass change (e.g., BMI, BMI percentiles and Z-scores, waist circumference) and diet quality for the index parent and their enrolled biological offspring.
This dietary program is based on empirical evidence showing that a diet pattern that favors minimally processed and whole foods (e.g., whole grains, fruits, vegetables, nuts) in contrast to diet patterns with greater consumption of highly refined and ultra-processed foods are attributed to greater reductions in HbA1c and fasting plasma glucose and a reduced risk for T2D. This evidence comes primarily from prospective cohort and clinical studies of 1) adult populations without diabetes (including type 2 and pre-diabetes) and 2) adult populations with active T2D. Studies of family dietary interventions for transgenerational T2D prevention are lacking.
Studies have focused primarily on structured diet patterns such as the Mediterranean style, Vegetarian or Vegan, Dietary Approaches to Stop Hypertension (DASH), carbohydrate-restricted, and low-fat. Evidence supports that the diet patterns most effective for T2D risk reduction focused on primarily whole food consumption (e.g., Mediterranean-style, Vegetarian, and DASH). Yet, less attention has been given to studying the effectiveness of the Dietary Guidelines for American's (DGA) diet pattern which forms the basis of nutrition advice in the U.S. and is the guiding nutrition framework used for federal nutrition policy. Moreover, a benefit of the recent DGA is its customizable approach to diet.
Recognizing the importance of a whole foods structured diet and the recent shift of the Dietary Guidelines for American's DGA diet pattern towards a customizable, family-centered, whole foods approach, studies that test the effectiveness of a DGA-structured diet for T2D risk reduction should be prioritized. Before conducting efficacy and effectiveness trails, pilot data is needed to determine the feasibility and acceptability of using this family-centered diet approach in a population at "high risk" for T2D. Applying a family-lens where a transgenerational approach can be used to prevent T2D is necessary.
Therefore, this program aims are to design and test the feasibility of delivering a whole foods diet pattern using a family centered approach in a population at risk for T2D- adults with prediabetes and their "at-risk" biological offspring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Prediabetes Diet Intervention | Experimental | The diet intervention will consist of weekly food deliveries for a total of 2-weeks. The intervention will consist of a weekly individual counseling sessions led by the team's registered dietitian nutritionist (RDN). Prior to beginning the intervention, an initial individual and/or family meeting with the RDN will be scheduled. The focus of the meeting will be for the RDN to provide information about diet instruction, meal preparation/planning, and individual and family goal setting. Meetings can occur in person, via a secure zoom videoconference, or via telephone (per participant preference) and must take place with the index parent present, as they will be responsible for taking the lead of the diet intervention or relaying the information to the primary caregiver/spouse/partner in the household who is responsible for meal preparation/cooking. Child/adolescent participants will be instructed by the RDN on how to record their dietary intake (as age-appropriate) using a food diary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Prediabetes Diet Intervention | Behavioral | Participants will be instructed by RDN on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled adults in the study, the goal is to maintain complete diet adherence during the two-week intervention. The focus for children/adolescents will be on encouragement and exposure of the diet by the index parent and any additional household parent/guardian/caregiver. Participants will receive groceries that are tailored specifically to the prescribed diet menus/recipes for each week. Foods will be distributed using either a grocery delivery service or via participant pick-up. Each household will receive enough groceries to feed a household of four-persons for each week of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Adult and offspring adherence to the diet program | Adherence will be assessed by the number of days the National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) is completed to record dietary intake. The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool. ASA24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. | 2 weeks |
| Change in offspring diet quality pre-post intervention | The Healthy Eating Index-2015 scale was calculated from collected 24-hour dietary recall data collected using the ASA24 (Automated-Self Administered Recall System) a computerized dietary assessment tool. Data was collected through Automated Self-Administered 24-hour dietary recall to calculate HEI-2015 scores. The scores range from 0 to 100, with higher scores reflecting greater adherence with dietary recommendations from the Dietary Guidelines for Americans. A score of 100 reflects high adherence and a score of 0 reflects no adherence. | Baseline to two weeks |
| Change in Adult Body Mass Index (BMI) | Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese. | Baseline to two weeks |
| Change in Offspring Body Mass Index (BMI) percentiles | Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI percentiles. | Baseline to two weeks |
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Inclusion Criteria:
For this study, eligible adults will be those that:
For this study, eligible offspring (child(ren)/ adolescent(s)) will be those that:
Exclusion criteria:
Adult exclusion criteria include:
Offspring (child[ren] and adolescent[s]) exclusion criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Nadia M Sneed, PhD, FNP-BC | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University School of Nursing | Nashville | Tennessee | 37240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39444044 | Derived | Sneed NM, Kelley R, Turner H, Piano MR, Dagostino C, Sellers A, Bonnet K, Schlundt D, Adams LE, Heerman WJ. The development and testing of a single-arm feasibility and acceptability study of a whole foods diet intervention for adults with prediabetes and their offspring. Pilot Feasibility Stud. 2024 Oct 23;10(1):130. doi: 10.1186/s40814-024-01554-9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 30, 2022 | Sep 9, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change in Offspring Body Mass Index (BMI) Z Scores |
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI z-scores. |
| Baseline to two weeks |
| Change in Adult and Offspring Waist Measurements | Waist circumference will be measured in centimeters. | Baseline to two weeks |
| D004700 | Endocrine System Diseases |