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The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KP Personal Shopper Visits
In-Office Dietitian Visits
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight focused on measuring Dietary advice, Nutritional knowledge, Self-efficacy, Nutrition

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Employee population of a specific Southeastern U.S. County
  • 18-64 years of age
  • Body Mass Index greater than or equal to 30kg/m^2 (Obese)
  • Low rate of no-shows for office visits (<10%)
  • Saw PCP or other provider in past 12 months
  • Does at least 50% of the food shopping and/or food preparation for their household

Exclusion Criteria:

  • non-English speaking
  • Currently being treated for cancer (other than non-melanoma skin cancer)
  • Pregnant or planning pregnancy in the next 6 months
  • Had or considering having bariatric surgery
  • Currently participating in commercial weight loss program (e.g. Jenny Craig)
  • Currently enrolled in another weight management or nutrition study

Sites / Locations

  • Kaiser Permanente Center for Health Research, Southeast

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Grocery-Store-Based Visit Arm

Office-Based Visit Arm

Arm Description

25 participants will be randomized to this arm. They will receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They will then have 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits will be conducted monthly over a 3 month period. The information delivered in the visits will be similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.

25 participants will be randomized to this arm. They will receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They will then have 3 in-person visits with the dietitian conducted in an office at one of our medical office buildings. These in-person visits will be conducted monthly over a 3 month period. The information delivered in the visits will include how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.

Outcomes

Primary Outcome Measures

Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).
The Block FFQ will be administered at baseline in order to calculate a participant's baseline HEI score, and will be re-administered after the 3 month intervention to re-calculate the post-intervention HEI score. The numbers reported here represent the change from pre to post intervention, in the HEI scores for participants in each group HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. There are no units associated with the HEI score. The measure was developed by the US Dept of Agriculture and complete details regarding its development can be found on their website.

Secondary Outcome Measures

Nutritional Knowledge of Members
A modified version of the Parmenter-Wardle Nutrition Knowledge Questionnaire (1999, UK) has been created based on present-day guidelines and eating patterns in the Southeast U.S., and will be administered at baseline and scored, then re-administered after the intervention and re-scored to determine whether or how the score improved after the intervention with the dietitian.

Full Information

First Posted
April 18, 2013
Last Updated
March 1, 2017
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT01837524
Brief Title
The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized trial of grocery-store based nutrition counseling visits for weight management vs. in-office visits. The investigators will test pre- and post-intervention individual-level dietary quality, knowledge, self-efficacy around dietary choice, and cost of shopping, measuring difference between intervention and control arms. At the study's end, the investigators will also conduct focus groups with a subset of 20 patients (10 from each arm) and do a structured interview with the dietitian to better understand the feasibility, strengths and shortcomings of this approach. Patients who complete the main portion of the trial will be randomly selected for recruitment into a focus group and consented separately for that focus group at the end of the study. The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper visits will result in higher member diet quality scores, better nutritional knowledge scores, higher self-efficacy and confidence around food purchasing decisions, and more favorable perception of the visit by both dietician and member. The KP Personal Shopper approach may also result in increased grocery store costs for some members. Long-term, the investigators hypothesize that improvements in member perception, knowledge and dietary quality will lead to improved health outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Dietary advice, Nutritional knowledge, Self-efficacy, Nutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grocery-Store-Based Visit Arm
Arm Type
Experimental
Arm Description
25 participants will be randomized to this arm. They will receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They will then have 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits will be conducted monthly over a 3 month period. The information delivered in the visits will be similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
Arm Title
Office-Based Visit Arm
Arm Type
Active Comparator
Arm Description
25 participants will be randomized to this arm. They will receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They will then have 3 in-person visits with the dietitian conducted in an office at one of our medical office buildings. These in-person visits will be conducted monthly over a 3 month period. The information delivered in the visits will include how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.
Intervention Type
Behavioral
Intervention Name(s)
KP Personal Shopper Visits
Intervention Description
Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care.
Intervention Type
Behavioral
Intervention Name(s)
In-Office Dietitian Visits
Intervention Description
Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period.
Primary Outcome Measure Information:
Title
Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).
Description
The Block FFQ will be administered at baseline in order to calculate a participant's baseline HEI score, and will be re-administered after the 3 month intervention to re-calculate the post-intervention HEI score. The numbers reported here represent the change from pre to post intervention, in the HEI scores for participants in each group HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. There are no units associated with the HEI score. The measure was developed by the US Dept of Agriculture and complete details regarding its development can be found on their website.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Nutritional Knowledge of Members
Description
A modified version of the Parmenter-Wardle Nutrition Knowledge Questionnaire (1999, UK) has been created based on present-day guidelines and eating patterns in the Southeast U.S., and will be administered at baseline and scored, then re-administered after the intervention and re-scored to determine whether or how the score improved after the intervention with the dietitian.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Cost of Grocery Shopping for Members
Description
Receipts from a typical week's worth of grocery shopping will be collected from all participants at baseline. Then, the same process will be repeated each month during the intervention phase to see what effect participation has on costs of grocery shopping for participants (e.g. if buying more produce because shopping with dietitian - will shopping be more expensive?)
Time Frame
3 months
Title
Member Self-efficacy and Confidence in Food Purchasing Decisions
Description
Will be assessed using a brief survey at baseline (scored) and re-surveyed after the intervention. Survey questions are based on similar items from other studies of health behavior interventions.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Employee population of a specific Southeastern U.S. County 18-64 years of age Body Mass Index greater than or equal to 30kg/m^2 (Obese) Low rate of no-shows for office visits (<10%) Saw PCP or other provider in past 12 months Does at least 50% of the food shopping and/or food preparation for their household Exclusion Criteria: non-English speaking Currently being treated for cancer (other than non-melanoma skin cancer) Pregnant or planning pregnancy in the next 6 months Had or considering having bariatric surgery Currently participating in commercial weight loss program (e.g. Jenny Craig) Currently enrolled in another weight management or nutrition study
Facility Information:
Facility Name
Kaiser Permanente Center for Health Research, Southeast
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30305
Country
United States

12. IPD Sharing Statement

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The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice

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