Trial Outcomes & Findings for The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice (NCT NCT01837524)

Last Updated: 2017-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

3 months

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Grocery-Store-Based Visit Arm 28 participants were randomized to this arm. They were assigned to 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 were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was 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. 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.	Office-Based Visit Arm 27 participants were randomized to this arm. They were assigned to 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 were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included 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. 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.
Overall Study STARTED	28	27
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Grocery-Store-Based Visit Arm n=28 Participants 28 participants were randomized to this arm. They were assigned to 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 were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was 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. 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.	Office-Based Visit Arm n=27 Participants 27 participants were randomized to this arm. They were assigned to 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 were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included 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. 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.	Total n=55 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 10 • n=5 Participants	43.4 years STANDARD_DEVIATION 8.2 • n=7 Participants	44.3 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	27 participants n=7 Participants	55 participants n=5 Participants
Body Mass Index (BMI)	35.6 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	34.1 kg/m^2 STANDARD_DEVIATION 5.3 • n=7 Participants	34.8 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Grocery-Store-Based Visit Arm n=25 Participants 28 participants were randomized to this arm. They were assigned to 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 were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was 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. 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.	Office-Based Visit Arm n=25 Participants 27 participants were randomized to this arm. They were assigned to 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 were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included 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. 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.
Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).	5.2 points Standard Deviation 9.1	4.5 points Standard Deviation 9.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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?)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Grocery-Store-Based Visit Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Office-Based Visit Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristina Lewis

Kaiser Center for Clinical and Outcomes Research

Phone: 404-364-7150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place