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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01837524
First received: April 18, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: KP Personal Shopper Visits
Behavioral: In-Office Dietitian Visits

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Dietary quality scores of members as measured using the 2005 Healthy Eating Index (HEI). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Nutritional knowledge of members [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Cost of grocery shopping for members [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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?)

  • Member self-efficacy and confidence in food purchasing decisions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 55
Study Start Date: June 2013
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Grocery-Store-Based Visit Arm
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
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.
Active Comparator: Office-Based Visit Arm
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837524

Locations
United States, Georgia
Kaiser Permanente Center for Health Research, Southeast
Atlanta, Georgia, United States, 30305
Sponsors and Collaborators
Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01837524     History of Changes
Other Study ID Numbers: Pro00003988
Study First Received: April 18, 2013
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Dietary advice
Nutritional knowledge
Self-efficacy
Nutrition

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014