Trial Outcomes & Findings for Pilot Test of a Chinese Menu Plan for Type 2 Diabetes (NCT NCT02327429)

NCT ID: NCT02327429

Last Updated: 2017-06-27

Results Overview

Intake assessed pre-post intervention using a 3-day food record

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-06-27

Participant Flow

Participant milestones

Measure	A Chinese Menu Plan for Type 2 Diabetes All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.
Overall Study STARTED	19
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Test of a Chinese Menu Plan for Type 2 Diabetes

Baseline characteristics by cohort

Measure	A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.
Age, Continuous	66 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Canada	17 participants n=5 Participants
Age at Immigration	45 years STANDARD_DEVIATION 19 • n=5 Participants
Years in North America	21 years STANDARD_DEVIATION 19 • n=5 Participants
Duration of diabetes	11 years STANDARD_DEVIATION 8 • n=5 Participants
Acculturation score	1.9 units on a scale STANDARD_DEVIATION 0.4 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Energy Intake (3-day Food Record)

-299 kcal Standard Deviation 603

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Carbohydrate Intake (3-day Food Record)

0.4 percentage of total energy Standard Deviation 10.3

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Protein Intake (3-day Food Record)

1.7 percentage of total energy Standard Deviation 5.3

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Total Fat Intake (3-day Food Record)

0.6 percentage of total energy Standard Deviation 6.8

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Saturated Fat Intake (3-day Food Record)

0.1 percentage of total energy Standard Deviation 1.9

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Dietary Fibre Intake (3-day Food Record)

0.8 grams Standard Deviation 13.9

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Added Sucrose Intake (3-day Food Record)

0.2 percentage of total energy Standard Deviation 1.0

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Sodium Intake (3-day Food Record)

-275 milligrams Standard Deviation 981

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Calcium Intake (3-day Food Record)

124 milligrams Standard Deviation 341

PRIMARY outcome

Timeframe: 12 weeks

Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Cholesterol Intake (3-day Food Record)

11 milligrams Standard Deviation 130

SECONDARY outcome

Timeframe: 12 weeks

Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Hemoglobin A1c (A1c)

-0.13 % of A1c in blood Standard Deviation 0.49

SECONDARY outcome

Timeframe: 12 weeks

Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Body Mass Index (BMI)

-0.4 kg/m2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 weeks

Waist circumference measured pre-post intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Waist Circumference

-2.0 cm Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12 weeks

Fasting triglyceride measured pre-post intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Fasting Triglyceride

-1.2 mg/dL Standard Deviation 88.8

SECONDARY outcome

Timeframe: 12 weeks

Fasting total cholesterol measured pre-post intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Fasting Total Cholesterol

-21.4 mg/dL Standard Deviation 28.2

SECONDARY outcome

Timeframe: 12 weeks

Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Fasting Low-density Lipoprotein Cholesterol

-18.4 mg/dL Standard Deviation 24.6

SECONDARY outcome

Timeframe: 12 weeks

Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months

Outcome measures

Measure

A Chinese Menu Plan for Type 2 Diabetes n=17 Participants All participants will be in the intervention arm for this pilot study A Chinese menu plan for type 2 diabetes: The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.

Change in Fasting High-density Lipoprotein Cholesterol

-2.8 mg/dL Standard Deviation 20.5

Adverse Events

A Chinese Menu Plan for Type 2 Diabetes

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

Catherine Chan

University of Alberta

Phone: 780-492-9939

Email: cbchan@ualberta.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place