Why stopped (as posted): Insufficient metabolic kitchen support
Summary
Brief summary (as posted)
Native Hawaiian or other Pacific Islanders (NHPI) including those from Polynesia, Micronesia, and Melanesia, are the fastest growing racial/ethnic group in the U.S., but they are vastly underrepresented in health research. Compared with other racial/ethnic groups, NHPIs have higher risk of cancer, especially breast, colorectal and endometrial cancers. Moreover, NHPIs experience worse cancer-free survival, particularly among younger adults. There has been a concerning increase in incidence and deaths from cancer among NHPIs in recent years in parallel with persistent or widening health disparity gaps in cancer risk factors like poor diet quality, obesity, diabetes, and access to healthcare. Identifying culturally tailored ways to address these cancer risk factors in the NHPI community is therefore an urgent unmet need.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Cancer Prevention
—
UNRESOLVED
—
Interventions
Interventions (2)
Intervention
Type
Mapped drug
Match
Medically Tailored Meals (MTM)
Other
—
UNRESOLVED
Time Restricted Eating (TRE)
Other
—
UNRESOLVED
Design
Arms and outcomes
Arms (4)
type
NO_INTERVENTION
label
Control
description
Participants will continue their usual lifestyle.
type
EXPERIMENTAL
label
Time Restricted Eating (TRE)
description
Participants will complete the TRE schedule for 8 weeks.
interventionNames
Other: Time Restricted Eating (TRE)
type
EXPERIMENTAL
label
Medically Tailored Meals (MTM)
description
Participants will be given MTM for 8 weeks.
interventionNames
Other: Medically Tailored Meals (MTM)
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Native Hawaiian/Pacific Islander females aged 18 years or older
2. Have at least one cancer risk factor (BMI≥25kg/m2 OR have a history of non-insulin dependent diabetes OR have at least one metabolic syndrome criteria out of clinical range OR have a history of cancer precursors (e.g., atypical endometrial hyperplasia, colorectal adenoma, atypical ductal hyperplasia)
3. Have a working cell phone that can download an App
4. Able to use cell phone during day (e.g. at work)
5. Not a night shift worker
6. Able to attend study visits at the Huntsman Cancer Institute Center for HOPE
7. Not on a special diet
8. Fast \<14-hours per night (i.e., eat all calorie containing foods over \>10-hours/day)
Exclusion Criteria:
1. Unable to provide informed consent
2. Necessity of a special diet
3. Have a history of insulin dependent diabetes
4. Have a history of hysterectomy
5. Fast \>14-hours per night/\<10-hour eating window
References
Publications (169)
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type
EXPERIMENTAL
label
Time Restricted Eating (TRE) + Medically Tailored Meals (MTM)
description
Participants will complete the TRE schedule and be given MTM for 8 weeks.
interventionNames
Other: Time Restricted Eating (TRE)
Other: Medically Tailored Meals (MTM)
Primary outcomes (3)
measure
Proportion of women recruited/consented - Feasibility
timeFrame
From enrollment to the 6-month follow up survey.
description
To determine the feasibility, fidelity, and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer.
This outcome measure will report the proportion of women referred who were recruited and consented to the trial. The study will be considered feasible if \>70% of women approached consent to the study.
measure
C-Peptide - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Hyperinsulinemia is a condition of too much insulin in the blood and is a cancer risk factor. C-peptide measures the amount of C-peptide in the blood and is an indicator of hyperinsulinemia.
This outcome measure will report the mean C-peptide of each group at 8 weeks after the initiation of the intervention.
measure
Depression - Emotional well-being
timeFrame
From enrollment to the 6 month follow up survey
description
To compare TRE, MTM, TRE + MTM, and Control for effects on emotional well-being among NHPI women at risk of obesity-related cancer.
Depression will be assessed with the Patient Health Questionnaire (PHQ-9). Scores range from 1-27, with lower scores indicating minimal depression and higher scores indicating more severe depression. A reduction of 5 points is considered clinically meaningful. This outcome measure will report the mean PHQ-9 scale of each group at 8 weeks after the initiation of the intervention.
Secondary outcomes (26)
measure
Attrition - Feasibility
timeFrame
From enrollment to the 6 month follow up survey
description
To determine the feasibility, fidelity, and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer.
This outcome measure will report the study's attrition, or the number of participants who drop out of this trial after randomization. The study will be considered feasible if \>70% of women randomized complete the study.
measure
Study Procedures Completed - Feasibility
timeFrame
From enrollment to the 6 month follow up survey
description
To determine the feasibility, fidelity, and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer.
This outcome measure will report the proportion of scheduled biospecimen collections and questionnaires that were completed. The study will be considered feasible if study participants complete 100% of biospecimen collections and questionnaires.
measure
TRE Adherent Days - Feasibility
timeFrame
From enrollment to the 6 month follow up survey
description
To determine the feasibility, fidelity, and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer.
This outcome measure will report the mean number of TRE or MTM adherent days per week. Participants will be considered adherent if they fasted between 14-18 h per day during the TRE phase according to mealtime log. The study will be considered feasible if participants adhere to the TRE protocol for at least 5/7 days per week.
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measure
Meals Delivered - Feasibility
timeFrame
From enrollment to the 6 month follow up survey
description
To determine the feasibility, fidelity, and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer.
This outcome measure will report the proportion of meals delivered on schedule. Fidelity will be evaluated as % protocol checklist items delivered as intended with a goal of 90%.
measure
Protocol Items Delivered as Intended - Fidelity
timeFrame
From enrollment to the 6 month follow up survey
description
To determine the feasibility, fidelity, and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer.
This outcome measure will report the proportion of protocol checklist items delivered as intended. Fidelity will be achieved if 90% of protocol checklist items are delivered as intended.
measure
Waist/hip - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6 month follow up survey
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Waist/hip ratio is waist circumference divided by hip circumference. This outcome measure will report the mean waist/hip ratio of each group at 8 weeks after the initiation of the intervention.
measure
Weight - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
This outcome measure will report the mean weight ratio of each group at 8 weeks after the initiation of the intervention.
measure
Body composition - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Body composition is the percentage (%) of weight that is fat tissue. This outcome measure will report the mean body composition of each group at 8 weeks after the initiation of the intervention.
measure
C-reactive protein - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
C-reactive protein (CRP) is the amount of a protein made by the liver. CRP is a risk of obesity-related cancer. This outcome measure will report the mean CRP of each group at 8 weeks after the initiation of the intervention.
measure
Fasting glucose - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Fasting glucose is the amount of glucose in the blood after abstaining from food for 8 hours. This outcome measure will report the mean fasting glucose of each group at 8 weeks after the initiation of the intervention.
measure
Fasting insulin - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Fasting glucose is the amount of insulin in the blood after abstaining from food for 8 hours. This outcome measure will report the mean fasting insulin of each group at 8 weeks after the initiation of the intervention.
measure
24-hour glucose - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
24-hour glucose is the mean glucose in the blood over 24 hours. This outcome measure will report the mean 24-hour glucose of each group at 8 weeks after the initiation of the intervention.
measure
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
HOMA-IR is an equation used to quantify insulin resistance. This outcome measure will report the mean HOMA-IR of each group at 8 weeks after the initiation of the intervention.
measure
Low-density lipoprotein (LDL) - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Low-density lipoprotein (LDL) is an atherogenic lipid that is a risk of obesity-related cancer. This outcome measure will report the mean LDL of each group at 8 weeks after the initiation of the intervention.
measure
Blood pressure - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
This outcome measure will report the mean blood pressure of each group at 8 weeks after the initiation of the intervention.
measure
Lipidomics - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
This outcome measure will report the lipidomics of each group at 8 weeks after the initiation of the intervention.
measure
Metabolomics - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
This outcome measure will report the metabolomics of each group at 8 weeks after the initiation of the intervention.
measure
Appetite - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Appetite will be measured as a single self-reported item. This outcome measure will report the responses of each group at 8 weeks after the initiation of the intervention.
measure
Diet quality - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Diet quality will be assess by the Healthy Eating Index (HEI)-2020 and assessed via 24-hour recall.
The HEI-2020 score is a quantification of well diet aligns with the Dietary Guidelines for Americans. HEI-2020 has a maximum total score of 100 and a minimum score of 0, with higher scores indicating better alignment with dietary guidelines and lower scores indicating poorer alignment.
This outcome measure will report the mean HEI-2020 of each group at 8 weeks after the initiation of the intervention.
measure
Sleep Quality - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Sleep quality will be measured as a single, self-reported item on a survey. This outcome measure will report the count of responses from each group at 6 months after the initiation of the intervention.
measure
Sleep Duration - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Sleep duration will be objectively measured on a research-grade accelerometer worn on the wrist. This outcome measure will report the mean sleep duration of each group at 8 weeks after the initiation of the intervention.
measure
Physical Activity - Effects on Metabolic Cancer Risk
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer.
Physical activity will be objectively measured on a research-grade accelerometer worn on the wrist. This outcome measure will report the mean daily steps of each group at 8 weeks after the initiation of the intervention.
measure
Anxiety - Emotional Well-being
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on emotional well-being among NHPI women at risk of obesity-related cancer.
Anxiety will be assessed with the Generalized Anxiety Disorder 7-item survey (GAD-7). Scores range from 0-15, with lower scores indicating minimal anxiety and higher scores indicating more severe anxiety.
This outcome measure will report the mean GAD-7 score of each group at 8 weeks after the initiation of the intervention.
measure
Alcohol Use - Emotional Well-being
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on emotional well-being among NHPI women at risk of obesity-related cancer.
Alcohol use will be assessed with the Alcohol use disorders identification test (AUDIT-C). Scores range from 0-12, with lower scores indicating minimal alcohol use and higher scores indicating more severe alcohol use.
This outcome measure will report the mean AUDIT-C score of each group at 8 weeks after the initiation of the intervention.
measure
Health status - Emotional Well-being
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on emotional well-being among NHPI women at risk of obesity-related cancer.
Health status will be assessed by a single, self-reported item. Subject will be asked to report their general health status from 1, Excellent to 5, Poor
This outcome measure will report the count of participants selecting each response at 6 months after the initiation of the intervention.
measure
Acculturative stress - Emotional Well-being
timeFrame
From enrollment to the 6-month follow up survey.
description
To compare TRE, MTM, TRE + MTM, and Control for effects on emotional well-being among NHPI women at risk of obesity-related cancer.
Acculturative stress will be assessed with the Pacific Islands cultural orientation acculturative stress survey (PIACCULT). This is a self reported, 11-item assessment.
Scores range from 11-55, with lower scores indicating worse Pacific cultural orientation and higher scores indicating more Pacific cultural orientation.
This outcome measure will report the mean PIACCULT score of each group at 6 months after the initiation of the intervention.