Trial Outcomes & Findings for Study of Household Purchasing Patterns, Eating and Recreation (NCT NCT02073643)

NCT ID: NCT02073643

Last Updated: 2019-03-25

Results Overview

Diet quality was quantified by applying the Healthy Eating Index-2015 (HEI-2015) scoring criteria (https://epi.grants.cancer.gov/hei/) to the nutrient and food group data of purchased foods and beverages. The HEI-2015 scores adherence to the Department of Health and Human Services' 2015 Dietary Guidelines for Americans. Adherence to recommended intakes for 13 key dietary components is scored on continuous scale for each component, and the 13 component scores are then summed to obtain a total score ranging from 0-100. Higher scores reflect closer adherence to the dietary guidelines.

Recruitment status

COMPLETED

Target enrollment

204 participants

Primary outcome timeframe

2 weeks

Results posted on

2019-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Main Food Purchasing Cohort This is a cohort study.
Overall Study STARTED	204
Overall Study COMPLETED	180
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Food Purchasing Cohort This is a cohort study.
Overall Study Lost to Follow-up	24

Baseline Characteristics

Study of Household Purchasing Patterns, Eating and Recreation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Cohort n=204 Participants This is a cohort study.
Age, Continuous	44.11 years STANDARD_DEVIATION 13.21 • n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	93 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	27 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	204 participants n=5 Participants
Body mass index	31.15 kg/m^2 STANDARD_DEVIATION 9.08 • n=5 Participants
Delay discounting	32.77 (Value of $100) * (days until receipt) STANDARD_DEVIATION 28.54 • n=5 Participants
Systolic blood pressure	120.19 mmHg, systolic STANDARD_DEVIATION 15.29 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: N=202 participants had food purchase data available for analysis.

Outcome measures

Outcome measures
Measure	Main Cohort n=202 Participants This is a cohort study.
Diet Quality of Household Food Purchases	57.88 units on a scale Standard Deviation 15.22

SECONDARY outcome

Timeframe: 2 weeks

Diet quality was quantified by applying the Healthy Eating Index-2015 (HEI-2015) scoring criteria (https://epi.grants.cancer.gov/hei/) to the nutrient and food group data derived from three 24-hour diet recalls. The HEI-2015 scores adherence to the Department of Health and Human Services' 2015 Dietary Guidelines for Americans. Adherence to recommended intakes for 13 key dietary components is scored on continuous scale for each component, and the 13 component scores are then summed to obtain a total score ranging from 0-100. Higher scores reflect closer adherence to the dietary guidelines.

Outcome measures

Outcome measures
Measure	Main Cohort n=204 Participants This is a cohort study.
Diet Quality of Dietary Intake	59.49 units on a scale Standard Deviation 14.38

SECONDARY outcome

Timeframe: 2 weeks

Availability of obesity promoting foods in the home, assessed with an audit-based inventory. The audit captures the presence of 71 "obesity promoting" foods. The sum of these items ranges from 0-71, with higher scores reflecting greater availability in the home.

Outcome measures

Outcome measures
Measure	Main Cohort n=204 Participants This is a cohort study.
Home Food Environment	20.19 units on a scale Standard Deviation 8.76

SECONDARY outcome

Timeframe: 2 weeks

Population: N=202 subjects had food purchase data available for analysis

Percentage of total energy (kcal) purchased from all sources other than food stores/supermarkets, including fast food and take-out/delivery, full-service restaurants, vending machines, bars/taverns, and cafeterias.

Outcome measures

Outcome measures
Measure	Main Cohort n=202 Participants This is a cohort study.
Percentage of Total Energy Purchased From Non-store Sources (e.g., Fast Food and Take-out/Delivery, Restaurants)	10.65 Percentage of total energy purchased Interval 2.55 to 24.01

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: N=179 participants had blood pressure readings at both baseline and the 12-month follow up.

Change in systolic blood pressure

Outcome measures

Outcome measures
Measure	Main Cohort n=179 Participants This is a cohort study.
Change From Baseline in Systolic Blood Pressure at 12 Months	1.00 change in mmHg, systolic Standard Deviation 14.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: N=180 participants completed the 12-month follow up assessment

Change in body mass index over 12 months of follow up

Outcome measures

Outcome measures
Measure	Main Cohort n=180 Participants This is a cohort study.
Change From Baseline in Body Mass Index at 12 Months	0.23 difference in kg/m^2 Standard Deviation 1.69

Adverse Events

Main Cohort

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

Brad Appelhans, PhD

Rush University Medical Center

Phone: 312-942-3477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place