Trial Outcomes & Findings for Cooking for Health (NCT NCT03699709)

Results Overview

Sugar-sweetened beverages include self-reported intake of fruit drinks, sugar-based energy drinks, and soda. Intake of sugar-sweetened beverages will be estimated using measures of consumption frequency and portion size. Average intakes will be calculated for each study participant using the University of Minnesota Nutrition Data Systems for Research Software by multiplying the frequency response for each beverage on the food frequency questionnaire by the recalled portion size, and then summing for all relevant beverages. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to decrease intake of sugar-sweetened beverages, lower (i.e., more negative) after - before differences represent a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

176 participants

Primary outcome timeframe

measured at baseline, and months 6 and 12

Results posted on

2025-03-18

Participant Flow

No significant events after participant enrollment, but prior to randomization to intervention or control arm.

Participant milestones

Participant milestones
Measure	Intervention Arm Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)
Overall Study STARTED	88	88
Overall Study Month 6 Visit	74	79
Overall Study COMPLETED	71	82
Overall Study NOT COMPLETED	17	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)
Overall Study Death	1	2
Overall Study Lost to Follow-up	10	3
Overall Study Withdrawal by Subject	5	0
Overall Study incarcerated	1	0
Overall Study scheduled, but no show	0	1

Baseline Characteristics

Cooking for Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=88 Participants Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm n=88 Participants No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)	Total n=176 Participants Total of all reporting groups
Age, Continuous	51.0 years STANDARD_DEVIATION 11.9 • n=5 Participants	48.3 years STANDARD_DEVIATION 11.2 • n=7 Participants	49.7 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	58 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	30 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	88 Participants n=5 Participants	88 Participants n=7 Participants	176 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Sugar-sweetened beverages	1.2 servings per day STANDARD_DEVIATION 2.4 • n=5 Participants	1.1 servings per day STANDARD_DEVIATION 1.6 • n=7 Participants	1.2 servings per day STANDARD_DEVIATION 2.0 • n=5 Participants
Unhealthy Food Purchases	39.4 purchases per 30 days STANDARD_DEVIATION 34.7 • n=5 Participants	51.2 purchases per 30 days STANDARD_DEVIATION 38.2 • n=7 Participants	45.3 purchases per 30 days STANDARD_DEVIATION 36.8 • n=5 Participants
Healthy Food Purchases	62.4 purchases per 30 days STANDARD_DEVIATION 56.0 • n=5 Participants	88.0 purchases per 30 days STANDARD_DEVIATION 75.2 • n=7 Participants	75.3 purchases per 30 days STANDARD_DEVIATION 67.4 • n=5 Participants

PRIMARY outcome

Timeframe: measured at baseline, and months 6 and 12

Population: Participants who completed the food frequency questionnaire at the baseline and month 6 exam or the baseline and month 12 exam

Sugar-sweetened beverages include self-reported intake of fruit drinks, sugar-based energy drinks, and soda. Intake of sugar-sweetened beverages will be estimated using measures of consumption frequency and portion size. Average intakes will be calculated for each study participant using the University of Minnesota Nutrition Data Systems for Research Software by multiplying the frequency response for each beverage on the food frequency questionnaire by the recalled portion size, and then summing for all relevant beverages. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to decrease intake of sugar-sweetened beverages, lower (i.e., more negative) after - before differences represent a better outcome.

Outcome measures

Outcome measures
Measure	Intervention Arm n=70 Participants Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm n=78 Participants No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)
Change (From Baseline) in Self-reported Intake (Servings/Day) of Sugar-sweetened Beverages (Measured Using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 Months and 12 Months 12 months-baseline	-0.13 servings Standard Error 0.38	-0.11 servings Standard Error 0.28
Change (From Baseline) in Self-reported Intake (Servings/Day) of Sugar-sweetened Beverages (Measured Using the Nutrition Assessment Shared Resource Food Frequency Questionnaire) at 6 Months and 12 Months 6 months-baseline	-0.22 servings Standard Error 0.23	-0.28 servings Standard Error 0.21

PRIMARY outcome

Timeframe: measured at baseline, and months 6 and 12

Population: Participants who completed the healthy and unhealthy food purchases questionnaire at the baseline and month 6 exam or the baseline and month 12 exam

Change in healthy and unhealthy food purchases will be estimated using the Healthy/Unhealthy Food Acquisition Survey. The survey includes a list of 47 healthy and unhealthy foods commonly consumed in the community. At each exam (baseline, month 6, month 12), participants will report the number of times he/she acquired each of the 47 foods in the past 30 days. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase the number of healthy food purchases and decrease the number of unhealthy food purchases, higher after - before differences represent a better outcome for healthy foods and lower after - before differences represent a better outcome for unhealthy foods.

Outcome measures

Outcome measures
Measure	Intervention Arm n=72 Participants Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm n=82 Participants No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)
Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months 12 months-baseline, unhealthy food purchases	-7.4 purchases per 30 days Standard Error 3.3	-10.1 purchases per 30 days Standard Error 3.7
Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months 6 months-baseline, unhealthy food purchases	-6.42 purchases per 30 days Standard Error 4.92	-9.91 purchases per 30 days Standard Error 4.25
Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months 12 months-baseline, healthy food purchases	7.24 purchases per 30 days Standard Error 4.95	-16.3 purchases per 30 days Standard Error 8.56
Change (From Baseline) in Healthy and Unhealthy Food Purchases (Measured Using the Healthy/Unhealthy Food Acquisition Survey) at 6 Months and 12 Months 6 months-baseline, healthy food purchases	0.84 purchases per 30 days Standard Error 6.3	-10.5 purchases per 30 days Standard Error 0.84

SECONDARY outcome

Timeframe: measured at baseline, and months 6 and 12

Population: Participants who completed the Food Resource Management questions at the baseline and month 6 exam or the baseline and month 12 exam

Change in food budgeting skills will be estimated using the Food Resource Management Scale. The scale includes 4 questions related to shopping behaviors to maximize food resources. The Food Resource Management Scale is a Likert-type scale with responses ranging from 1 (never) to 5 (always). Responses to the four questions will be averaged to create a total Food Resource Management Score. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase food budgeting skills, higher after-before differences represent a better outcome.

Outcome measures

Outcome measures
Measure	Intervention Arm n=73 Participants Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm n=80 Participants No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)
Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months 12 months-baseline	0.28 score on a scale Standard Error 0.11	-0.08 score on a scale Standard Error 0.10
Change (From Baseline) in Food Budgeting Skills (Measured Using the Food Resource Management Scale) at 6 Months and 12 Months 6 months-baseline	0.08 score on a scale Standard Error 0.12	0.05 score on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: measured at baseline, and months 6 and 12

Population: Participants who completed the Cooking Confidence Scale questions at the baseline and month 6 exam or the baseline and month 12 exam

Change in cooking skills will be estimated using a minor modification of the Cooking Confidence Scale. The Cooking Confidence Scale includes 6 questions related to confidence in preparing healthy foods. It is a Likert-type scale with responses ranging from 1 (not at all confident) to 5 (very confident). Responses to the questions will be averaged. Change from baseline with be assessed at 6 months and 12 months (12 months - baseline; 6 months - baseline). As the intervention hopes to increase cooking skills, higher after - before differences represent a better outcome.

Outcome measures

Outcome measures
Measure	Intervention Arm n=68 Participants Budgeting, purchasing and cooking educational intervention: Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum	Control Arm n=78 Participants No intervention (all intervention materials were given to participants randomized to the control arm at the end of the study)
Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months 12 months-baseline	0.16 score on a scale Standard Error 0.08	-0.18 score on a scale Standard Error 0.09
Change (From Baseline) in Cooking Skills (Measured Using the Cooking Confidence Scale) at 6 Months and 12 Months 6 months-baseline	0.21 score on a scale Standard Error 0.06	-0.06 score on a scale Standard Error 0.08

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amanda Fretts

University of Washington School of Public Health Department of Epidemiology

Phone: 2065431065

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place