NCT02124135

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

April 24, 2014

Last Update Submit

August 15, 2017

Conditions

Keywords

Nutrition

Outcome Measures

Primary Outcomes (4)

  • Change in Fruit and Vegetable Intake

    Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.

    3 months

  • Change in Whole Grain Intake

    Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.

    3 months

  • Change in Saturated Fat Intake

    Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.

    3 months

  • Change in Added Sugars Intake

    Will be measured in one parent and one child per enrolled family using the Block food screeners for adults and children.

    3 months

Secondary Outcomes (2)

  • Change in Nutritional Knowledge of Families

    3 months

  • Self-efficacy around food purchasing and dietary decisions

    3 months

Study Arms (2)

Clinic-based counseling

ACTIVE COMPARATOR

Participants in this arm will receive 1 baseline phone call with the registered dietitian to get preliminary dietary counseling tailored to their family's needs. They will then have 3 sessions in-person in a group setting with another family and the registered dietitian where a set dietary curriculum geared at promoting weight loss and/or maintenance of a healthy weight will be emphasized. All in-person visits will take place in the clinic setting.

Behavioral: Diet/Nutrition Education

Restaurant-based counseling

EXPERIMENTAL

Participants in this arm will receive 1 baseline phone call with the registered dietitian to get preliminary dietary counseling tailored to their family's needs. They will then have 3 sessions in-person in a group setting with another family and the registered dietitian where a set dietary curriculum geared at promoting weight loss and/or maintenance of a healthy weight will be emphasized. All in-person visits will take place in a restaurant, while dining.

Behavioral: Diet/Nutrition Education

Interventions

As described elsewhere, all participants will receive 1 phone call and 3 in person sessions with the registered dietitian. Participants in the "clinic" arm will receive the education intervention in the clinic. Participants in the "restaurant" arm will receive the education intervention while dining in a restaurant.

Clinic-based counselingRestaurant-based counseling

Eligibility Criteria

Age8 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research, Southeast

Atlanta, Georgia, 30305, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kristina H Lewis, MD MPH SM

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Investigator

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations