Clinical trial NCT02124135: Eat Out With KP: A Pilot to Improve the Impact of Dietary Advice for Families
Official title: Eat Out With KP: A Pilot to Improve the Impact of Dietary Advice for Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Nutrition
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 94
Sex: ALL
Minimum age (years): 8
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* adult member of Kaiser Georgia, in a specific employer group
* families in which at least one parent and one child are obese
* family with 2 or fewer children all between 8-13 years of age
* no-show rate for clinic visits \<10%
* adult is 18-64 years of age

Primary outcomes:
measure: Change in Fruit and Vegetable Intake
timeFrame: 3 months
measure: Change in Whole Grain Intake
timeFrame: 3 months
measure: Change in Saturated Fat Intake
timeFrame: 3 months
measure: Change in Added Sugars Intake
timeFrame: 3 months
Secondary outcomes:
measure: Change in Nutritional Knowledge of Families
timeFrame: 3 months
measure: Self-efficacy around food purchasing and dietary decisions
timeFrame: 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Center for Health Research, Southeast
state: Georgia
Study officials:
affiliation: Kaiser Permanente
name: Kristina H Lewis, MD MPH SM
role: PRINCIPAL_INVESTIGATOR
References: