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.
Native Hawaiian and other Pacific Islanders (NHPI) from Polynesia, Micronesia, and Melanesia are the fastest growing racial/ethnic group in the U.S., but are vastly underrepresented in health research. NHPIs experience major disparities in risk of breast, colorectal, and endometrial cancers, and worse cancer-free survival, particularly among younger adults. There has been a concerning increase in cancer incidence and deaths 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 cancer risk factors in the NHPI community is therefore an urgent unmet need. Diet is a cornerstone of managing metabolic health for cancer prevention. Irregular meal timing can disrupt 24-hour circadian clock-regulated metabolism to promote metabolic dysfunction, whereas structured mealtimes realign circadian transcriptional programs to improve metabolic health. Time restricted eating (TRE) is a form of intermittent fasting where daily calories are eaten within 6-12 hours. TRE improves cancer risk factors including hyperinsulinemia and dyslipidemia, but has not been evaluated in NHPIs. The investigators conducted a pilot 6-month randomized, controlled, crossover trial to test the feasibility and acceptability of TRE for effects on metabolic health in NHPIs at risk of endometrial cancer (TIMESPAN, NCT04763902). TIMESPAN was designed with feedback from focus groups and the Community Advisory Board (CAB) of NHPIs. Participants received isocaloric, culturally tailored, pre-prepared meals to control underlying diet during TRE and control. Insulin/c-peptide, triglycerides, and blood pressure improved with each phase, but TRE had larger effects and improved mood, energy, and satiety. The prepared meals addressed food insecurity and educated participants on healthy eating and portion control, goals of Medically Tailored Meals (MTM). A limitation was that the investigators did not measures effects of TRE without diet control. Since communal eating is integral to NHPI customs,13 participants reported that not providing family meals was a barrier. The investigators propose to provide family meals and include a TRE arm without diet control in the, "Family-Based Meal Timing for Cancer Prevention among Native Hawaiian and other Pacific Islanders: FAMTIME" study. The long-term goal of this study is to address cancer risk disparities in NHPIs using diet strategies. The investigators will recruit 10 NHPI females at risk of obesity-related cancer (i.e., hyperglycemia, dyslipidemia, overweight/obese, history of diabetes, or cancer precursor lesions) who fast \<12-hrs/day. Participants will complete a 2-week run-in period, then be randomized to 8-weeks' of (1) Control, (2) MTMs (healthy Polynesian diet), (3) TRE with usual diet, or (4) TRE + MTMs. Participants will also complete a 6-month follow-up. Family social support via communal eating will be encouraged. The myCircadianClock (mCC) app will evaluate and promote compliance. The central hypothesis is that MTM and TRE will improve metabolic and mental health among NHPI females at risk of obesity-related cancer; MTM+TRE will be multiplicative. Aim 1. Determine the feasibility, fidelity and preliminary acceptability of TRE and MTM among Pacific Islander women at risk for developing endometrial cancer. Participants will be randomized using stratification by age group and BMI category to balance groups according to those variables. Feasibility will be evaluated by: (1) Proportion (%) of women referred that were recruited and consented; (2) attrition as a function of time; (3) % of scheduled biospecimen collections and questionnaires completed; (4) 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); (5) % meals delivered on schedule. The study will be considered feasible if \>70% women are consented and retained, complete all biospecimen collections and questionnaires, and if women adhere to the TRE protocol for at least 5/7 days per week. Fidelity will be evaluated as % protocol checklist items delivered as intended with a goal of 90%. Aim 2. Compare TRE, MTM, TRE + MTM, and Control for effects on metabolic cancer risk factors among NHPI women at risk of obesity-related cancer. Primary outcome: hyperinsulinemia (C-peptide). Secondary outcomes: waist/hip ratio, weight, body composition, c-reactive protein, fasting glucose/insulin, 24-hour glucose, HOMA-IR, atherogenic lipids, blood pressure, blood metabolites related to cancer risk, appetite, diet quality, sleep quality/duration, and physical activity. Aim 3. Compare TRE, MTM, TRE + MTM, and Control for effects on emotional wellbeing among NHPI women at risk of obesity-related cancer. Focus groups and the CAB reported that mental wellbeing is the most important outcome to NHPI women, yet it is rarely discussed or evaluated. The primary outcome is depression (PHQ-9). Secondary outcomes: anxiety, alcohol use, health status, social support, and acculturative stress. These outcome measures were endorsed by the CAB as being particularly relevant. Aim 4. Qualitatively investigate the roles of social support and mental health in diet behavior change among NHPI women at risk of obesity-related cancer and their household. The investigators will build upon the themes that emerged from TIMESPAN by conducting focus groups among (1) FAMTIME participants and their household members, (2) the CAB, to interpret outcomes and evaluate the intervention from a cultural perspective. The investigators will explore in-depth the roles of social support, mental health, and food security in behavior change, and how to optimize cancer prevention interventions for high impact in the NHPI community.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2
For 8 weeks, participants will consume calorie containing foods and beverages within a personalized eating window up to 4-hours \< baseline (e.g., 14-hr 10hr; 13hr 9-hr), but not \>10-hours. Eating will start within 3-hours from waking and finish at least 3-hours before bedtime.
For 8 weeks, participants will receive isocaloric, culturally tailored, nutritionally balanced lunch and dinner pre-prepared meals, plus a breakfast and snack menu that meets daily calorie requirements for weight maintenance.
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Proportion of women recruited/consented - Feasibility
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.
Time frame: From enrollment to the 6-month follow up survey.
C-Peptide - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Depression - Emotional well-being
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.
Time frame: From enrollment to the 6 month follow up survey
Attrition - Feasibility
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.
Time frame: From enrollment to the 6 month follow up survey
Study Procedures Completed - Feasibility
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.
Time frame: From enrollment to the 6 month follow up survey
TRE Adherent Days - Feasibility
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.
Time frame: From enrollment to the 6 month follow up survey
Meals Delivered - Feasibility
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%.
Time frame: From enrollment to the 6 month follow up survey
Protocol Items Delivered as Intended - Fidelity
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.
Time frame: From enrollment to the 6 month follow up survey
Waist/hip - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6 month follow up survey
Weight - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Body composition - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
C-reactive protein - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Fasting glucose - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Fasting insulin - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
24-hour glucose - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Low-density lipoprotein (LDL) - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Blood pressure - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Lipidomics - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Metabolomics - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Appetite - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Diet quality - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Sleep Quality - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Sleep Duration - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Physical Activity - Effects on Metabolic Cancer Risk
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.
Time frame: From enrollment to the 6-month follow up survey.
Anxiety - Emotional Well-being
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.
Time frame: From enrollment to the 6-month follow up survey.
Alcohol Use - Emotional Well-being
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.
Time frame: From enrollment to the 6-month follow up survey.
Health status - Emotional Well-being
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.
Time frame: From enrollment to the 6-month follow up survey.
Acculturative stress - Emotional Well-being
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.
Time frame: From enrollment to the 6-month follow up survey.
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