Viewing Study NCT02124135


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Study NCT ID: NCT02124135
Status: COMPLETED
Last Update Posted: 2017-08-18
First Post: 2014-04-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Eat Out With KP: A Pilot to Improve the Impact of Dietary Advice for Families
Sponsor: Kaiser Permanente
Organization:

Study Overview

Official Title: Eat Out With KP: A Pilot to Improve the Impact of Dietary Advice for Families
Status: COMPLETED
Status Verified Date: 2017-08
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: Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. We will study the effect of relocating family weight management counseling sessions into restaurants, where registered dieticians and patients will conduct scheduled group visits while enjoying a meal together. As with office-based visits, our goal is for members and their families to learn how to select food options based on their unique health needs, budgetary concerns, and time constraints. In contrast to a traditional counseling visit, however, co-dining with a dietitian will give members a hands-on experience designed to enhance their learning and improve adherence. The proposed study would build on an existing pilot of a similar program, the "KP Personal Shopper", where dietitian visits were conducted with individuals either in the clinic setting or while shopping in a grocery store.

We will compare the new "Eat Out with Kaiser" approach to the current standard of clinic-based dietary and lifestyle counseling for weight management among 40 families affected by obesity, with the following outcomes in mind:

1. Change in dietary measures
2. Nutritional knowledge of families
3. Participant self-efficacy and confidence in food purchasing decisions
4. Participant and dietician perception of visit

We hypothesize that, compared to clinic-based visits, our "Eat Out with Kaiser" visits will result in more favorable perception of the visit by both dietitian and participant, higher nutritional knowledge scores, higher self-efficacy and confidence of patients around food decisions, and larger improvements in diet components.
Detailed Description: Dietary counseling at the point of purchase could improve patient adherence to dietary advice and downstream health outcomes. The aim of our pilot is to test the efficacy of a novel delivery system for dietary advice. We will study the effect of relocating family weight management counseling sessions into restaurants, where registered dieticians and patients will conduct scheduled group visits while enjoying a meal together. As with office-based visits, our goal is for members and their families to learn how to select food options based on their unique health needs, budgetary concerns, and time constraints. In contrast to a traditional counseling visit, however, co-dining with a dietitian will give members a hands-on experience designed to enhance their learning and improve adherence. The proposed study would build on an existing pilot of a similar program, the "KP Personal Shopper", where dietitian visits were conducted with individuals either in the clinic setting or while shopping in a grocery store.

Our study population will come from a local employer group, and we will use the electronic medical record to identify families where at least one child and one parent are affected by obesity. Assuming families are interested and meet eligibility criteria, they will be enrolled in the study.

Our study design is a randomized trial, where randomization occurs at the unit of the family. 45 families will be randomized into one of two arms. All families will receive a baseline 30 minute phone call with the dietitian, followed by three in-person group visits. Those in the intervention (Eat Out) arm will have their in-person visits conducted during mealtimes at a restaurant. Those in the control (clinic) arm will have their in-person visits conducted in a classroom at a Kaiser medical office building.

We will compare the new "Eat Out with Kaiser" approach to the current standard of clinic-based dietary and lifestyle counseling for weight management among 40 families affected by obesity, with the following outcomes in mind:

1. Change in dietary measures including - Fruit and Vegetable Intake, Whole Grain Intake, Saturated Fat Intake and Added Sugars.
2. Nutritional knowledge of families
3. Participant self-efficacy and confidence in food purchasing decisions - all family members
4. Participant and dietician perception of visit type (attendance, feasibility, effectiveness, e.g.)

We hypothesize that, compared to clinic-based visits, our "Eat Out with Kaiser" visits will result in more favorable perception of the visit by both dietitian and participant, higher nutritional knowledge scores, higher self-efficacy and confidence of patients around food decisions, and larger improvements in diet components.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: