Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482944
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-12
Brief Title:
Whole Food for Families A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Whole Food for Families A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will address the following aims
Aim 1 primary Conduct a pilot RCT to evaluate the feasibility acceptability enrollment and retention rates of adult-child pairs after a 12-week family-centered non-calorie restricted whole foods diet
Feasibility 80 participant retention and completion of study outcome measures
Acceptability 75 adult diet satisfaction via survey report andor perceived diet satisfaction via focus groups Aim 2 Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adultchild diet quality during the 12-week intervention
Aim 2a Evaluate intervention effects on HbA1c measures in adults with prediabetes
Hypothesis 2a Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group
Aim 2b Evaluate intervention effects on the diet quality via the 2020 HEI of adults and children Hypothesis 2b Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group
Aim 3 Conduct family focus groups to understand how SDOH and individualfamily needs and preferences may be perceived barriers or facilitators of diet adherence
Aim 1 primary Conduct a pilot RCT to evaluate the feasibility acceptability enrollment and retention rates of adult-child pairs after a 12-week family-centered non-calorie restricted whole foods diet
Feasibility 80 participant retention and completion of study outcome measures
Acceptability 75 adult diet satisfaction via survey report andor perceived diet satisfaction via focus groups Aim 2 Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adultchild diet quality during the 12-week intervention
Aim 2a Evaluate intervention effects on HbA1c measures in adults with prediabetes
Hypothesis 2a Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group
Aim 2b Evaluate intervention effects on the diet quality via the 2020 HEI of adults and children Hypothesis 2b Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group
Aim 3 Conduct family focus groups to understand how SDOH and individualfamily needs and preferences may be perceived barriers or facilitators of diet adherence
Detailed Description:
This dietary program is based on empirical evidence showing that a diet pattern that favors minimally processed and whole foods eg 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 eg Mediterranean-style Vegetarian and DASH Yet less attention has been given to studying the effectiveness of the Dietary Guidelines for Americans DGA diet pattern which forms the basis of nutrition advice in the US 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 Americans 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 test the feasibility and acceptability 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 This study will also test the preliminary effectiveness on the diets effects on change in adult hemoglobin A1c at 12 months and will assess changes in diet quality during the intervention in adults and offspring
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 eg Mediterranean-style Vegetarian and DASH Yet less attention has been given to studying the effectiveness of the Dietary Guidelines for Americans DGA diet pattern which forms the basis of nutrition advice in the US 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 Americans 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 test the feasibility and acceptability 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 This study will also test the preliminary effectiveness on the diets effects on change in adult hemoglobin A1c at 12 months and will assess changes in diet quality during the intervention in adults and offspring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None