NCT01837524

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 12, 2017

Completed
Last Updated

April 12, 2017

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

April 18, 2013

Results QC Date

April 1, 2015

Last Update Submit

March 1, 2017

Conditions

Keywords

Dietary adviceNutritional knowledgeSelf-efficacyNutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Nutritional Knowledge of Members

    3 months

Other Outcomes (2)

  • Cost of Grocery Shopping for Members

    3 months

  • Member Self-efficacy and Confidence in Food Purchasing Decisions

    3 months

Study Arms (2)

Grocery-Store-Based Visit Arm

EXPERIMENTAL

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.

Behavioral: KP Personal Shopper Visits

Office-Based Visit Arm

ACTIVE COMPARATOR

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.

Behavioral: In-Office Dietitian Visits

Interventions

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.

Grocery-Store-Based Visit Arm

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.

Office-Based Visit Arm

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Employee population of a specific Southeastern U.S. County
  • 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

You may not qualify if:

  • 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

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

OverweightObesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Kristina Lewis
Organization
Kaiser Center for Clinical and Outcomes Research

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 23, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

April 12, 2017

Results First Posted

April 12, 2017

Record last verified: 2014-01

Locations