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Completed

NCT Number: NCT01837524

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Center for Health Research, Southeast

Atlanta, Georgia, 30305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KP Personal Shopper Visits

Behavioral

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.

In-Office Dietitian Visits

Behavioral

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 outcomes

  1. Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).

    Time frame: 3 months

    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 outcomes

  1. Nutritional Knowledge of Members

    Time frame: 3 months

    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.

Other outcomes

  1. Cost of Grocery Shopping for Members

    Time frame: 3 months

    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?)

  2. Member Self-efficacy and Confidence in Food Purchasing Decisions

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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