Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464497
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-12
Brief Title:
Whole Foods for Teens A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Whole Foods for Teens A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
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 Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity
Aim 1a Primary Evaluate intervention effectiveness on total fat mass following the 8-week intervention
Hypothesis 1a Adolescents randomized to the whole foods intervention will have lower total fat mass kg at the 8-week follow-up than those in the control group
Aim 1b Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention
Hypothesis 1b Adolescents randomized to the whole foods intervention will have lower weight BMI-z scores andor waist circumference at the 8-week follow-up than those in the control group
Secondary Aims
Aim 2 Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period
Hypothesis 2 Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group
Aim 3 Conduct post-intervention family focus groups to identify how individualfamily needs and preferences and social determinants of health SDOH may be perceived barriers andor facilitators of diet adherence to a whole foods diet pattern
Aim 1 Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity
Aim 1a Primary Evaluate intervention effectiveness on total fat mass following the 8-week intervention
Hypothesis 1a Adolescents randomized to the whole foods intervention will have lower total fat mass kg at the 8-week follow-up than those in the control group
Aim 1b Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention
Hypothesis 1b Adolescents randomized to the whole foods intervention will have lower weight BMI-z scores andor waist circumference at the 8-week follow-up than those in the control group
Secondary Aims
Aim 2 Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period
Hypothesis 2 Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group
Aim 3 Conduct post-intervention family focus groups to identify how individualfamily needs and preferences and social determinants of health SDOH may be perceived barriers andor facilitators of diet adherence to a whole foods diet pattern
Detailed Description:
For adolescents with obesity a healthy diet pattern is recommended as a first-line non-pharmacological treatment Yet despite decades of research there is inconclusive evidence from randomized clinical trials RCT to support an optimal dietary pattern to treat adolescent obesity While observational data has linked poor-quality diet patterns high in calories fat and refined carbohydrates to greater body adiposity in adolescents some research suggests that dietary patterns that emphasize high-quality whole foods eg Mediterranean low-glycemic load not only improve diet quality but can also effectively reduce body adiposity and improve metabolic outcomes eg insulin resistance without the need for calorie restrictions However for adolescents with obesity adherence to a healthy diet pattern requires the involvement of the whole family with the potential to improve diet quality and reduce body adiposity and its associated metabolic complications Unfortunately weaknesses of past studies include 1 a failure to intervene upon diet quality at the family level to modify adolescent dietary behaviors and 2 a lack of consideration for how individualfamily needs and social determinants of health SDOH impact diet adoption To address these gaps we will test a novel 8-week pilot RCT of a non-calorie-restricted whole foods diet adapted from the 2020-2025 Dietary Guidelines for Americans that offers a simple customizable MyPlate Plan approach ie 5 daily food group goals focused on individual family cultural and budgetary preferences We will recruit 30 eligible adolescent 10-18 years and parent 25 years pairs to test the diets effects on 1 adolescent body adiposity measured with dual-energy x-ray absorptiometry DXA to measure fat mass and anthropometry to measure weight BMI and waist circumference Aim 1 and 2 adolescent and parent diet quality scores measured from dietary recalls using the 2020 Healthy Eating Index during the intervention Aim 2 Post-intervention family focus groups will be conducted to understand how individualfamily needs and preferences and SDOH may be perceived barriers or facilitators of diet adherence in families Aim 3 Feasibility acceptability enrollment retention and diet satisfaction data will be generated to establish successful benchmarks to support future studies Participants randomized to the intervention will receive bi- weekly food delivery menus and dietetic support for 8 weeks Participants randomized to the usual care group will receive a single dietetic counseling session on MyPlate The successful completion of this study will result in the generation of quantitative and qualitative data to support a future R01 that will test the long-term effectiveness of a whole foods diet on obesity and metabolic outcomes and diet sustainability in adolescents with obesity and their families
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