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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837524
• Other study ID #: Pro00003988
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: January 27, 2014
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research, Southeast	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of grocery shopping for members	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?)	3 months	No
Other	Member self-efficacy and confidence in food purchasing decisions	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.	3 months	No
Primary	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.	3 months	No
Secondary	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.	3 months	No