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AzTrials

Cancer PreventionFAMTIMENCT07262593

Family-Based Meal Timing for Cancer Prevention Among Native Hawaiian and Other Pacific Islanders: FAMTIME

A study testing Time Restricted Eating (TRE) and Medically Tailored Meals (MTM) in people with Cancer Prevention, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer Prevention
What is being tested?
Time Restricted Eating (TRE) and Medically Tailored Meals (MTM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Native Hawaiian/Pacific Islander females aged 18 years or older
  • 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)
  • Have a working cell phone that can download an App
  • Able to use cell phone during day (e.g. at work)
  • Not a night shift worker
  • Able to attend study visits at the Huntsman Cancer Institute Center for HOPE
  • Not on a special diet
  • Fast <14-hours per night (i.e., eat all calorie containing foods over >10-hours/day)

Who cannot join

  • Unable to provide informed consent
  • Necessity of a special diet
  • Have a history of insulin dependent diabetes
  • Have a history of hysterectomy
  • Fast >14-hours per night/<10-hour eating window

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Time Restricted Eating (TRE), Medically Tailored Meals (MTM)
Keywords
Diet, Time Restricted Eating, Quality of Life
Medical subject headings
Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time Restricted Eating (TRE)Other

    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.

  • Medically Tailored Meals (MTM)Other

    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.

Study groups in NCT07262593
Study groupRoleWhat they receive
ControlNo interventionParticipants will continue their usual lifestyle.
Time Restricted Eating (TRE)ExperimentalParticipants will complete the TRE schedule for 8 weeks.
Receives: Other: Time Restricted Eating (TRE)
Medically Tailored Meals (MTM)ExperimentalParticipants will be given MTM for 8 weeks.
Receives: Other: Medically Tailored Meals (MTM)
Time Restricted Eating (TRE) + Medically Tailored Meals (MTM)ExperimentalParticipants will complete the TRE schedule and be given MTM for 8 weeks.
Receives: Other: Time Restricted Eating (TRE); Other: Medically Tailored Meals (MTM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the 6-month follow up survey.

  2. 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.

    Measured: From enrollment to the 6-month follow up survey.

  3. 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.

    Measured: From enrollment to the 6 month follow up survey

Secondary outcomes (26)

  1. 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.

    Measured: From enrollment to the 6 month follow up survey

  2. 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.

    Measured: From enrollment to the 6 month follow up survey

  3. 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.

    Measured: From enrollment to the 6 month follow up survey

  4. 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%.

    Measured: From enrollment to the 6 month follow up survey

  5. 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.

    Measured: From enrollment to the 6 month follow up survey

  6. 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.

    Measured: From enrollment to the 6 month follow up survey

  7. 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.

    Measured: From enrollment to the 6-month follow up survey.

  8. 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.

    Measured: From enrollment to the 6-month follow up survey.

  9. 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.

    Measured: From enrollment to the 6-month follow up survey.

  10. 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.

    Measured: From enrollment to the 6-month follow up survey.

  11. 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.

    Measured: From enrollment to the 6-month follow up survey.

  12. 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.

    Measured: From enrollment to the 6-month follow up survey.

  13. 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.

    Measured: From enrollment to the 6-month follow up survey.

  14. 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.

    Measured: From enrollment to the 6-month follow up survey.

  15. 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.

    Measured: From enrollment to the 6-month follow up survey.

  16. 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.

    Measured: From enrollment to the 6-month follow up survey.

  17. 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.

    Measured: From enrollment to the 6-month follow up survey.

  18. 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.

    Measured: From enrollment to the 6-month follow up survey.

  19. 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.

    Measured: From enrollment to the 6-month follow up survey.

  20. 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.

    Measured: From enrollment to the 6-month follow up survey.

  21. 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.

    Measured: From enrollment to the 6-month follow up survey.

  22. 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.

    Measured: From enrollment to the 6-month follow up survey.

  23. 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.

    Measured: From enrollment to the 6-month follow up survey.

  24. 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.

    Measured: From enrollment to the 6-month follow up survey.

  25. 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.

    Measured: From enrollment to the 6-month follow up survey.

  26. 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.

    Measured: From enrollment to the 6-month follow up survey.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start1 Oct 2024
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Why it stopped: Insufficient metabolic kitchen support

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants received isocaloric, culturally tailored, pre-prepared meals to control underlying diet during TRE and control
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07262593
Sponsor's protocol ID
HCI166790
Acronym
FAMTIME
Status last verified
Dec 2025
First submitted
5 Sep 2023
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ethoan LN, Takata Y, Sakuma KK, Irvin VL. Trends in Clinical Research Including Asian American, Native Hawaiian, and Pacific Islander Participants Funded by the US National Institutes of Health, 1992 to 2018. JAMA Netw Open. 2019 Jul 3;2(7):e197432. doi: 10.1001/jamanetworkopen.2019.7432.

    PubMed 31339543

  • Liu L, Noone AM, Gomez SL, Scoppa S, Gibson JT, Lichtensztajn D, Fish K, Wilkens LR, Goodman MT, Morris C, Kwong S, Deapen D, Miller BA. Cancer incidence trends among native Hawaiians and other Pacific Islanders in the United States, 1990-2008. J Natl Cancer Inst. 2013 Aug 7;105(15):1086-95. doi: 10.1093/jnci/djt156. Epub 2013 Jul 22.

    PubMed 23878354

  • Terada K, Carney M, Kim R, Ahn HJ, Miyamura J. Health Disparities in Native Hawaiians and Other Pacific Islanders Following Hysterectomy for Endometrial Cancer. Hawaii J Med Public Health. 2016 May;75(5):137-9.

    PubMed 27239393

  • Kost ER, Hall KL, Hines JF, Farley JH, Nycum LR, Rose GS, Carlson JW, Fischer JR Jr, Kendall BS. Asian-Pacific Islander race independently predicts poor outcome in patients with endometrial cancer. Gynecol Oncol. 2003 May;89(2):218-26. doi: 10.1016/s0090-8258(03)00050-7.

    PubMed 12713983

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Equity. OoH. Twenty years of health data for Native Hawaiian/Pacific Islander communities in Utah. Salt Lake City, UT: 2023.

  • Subica AM, Agarwal N, Sullivan JG, Link BG. Obesity and Associated Health Disparities Among Understudied Multiracial, Pacific Islander, and American Indian Adults. Obesity (Silver Spring). 2017 Dec;25(12):2128-2136. doi: 10.1002/oby.21954. Epub 2017 Oct 25.

    PubMed 29071803

  • NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.

    PubMed 29029897

  • Research. WCRFAIfC. Continuous Update Project Expert Report 2018 2018 [Accessed 10th September, 2023]. Available from: Available at dietandcancerreport.org

  • Petersen MC, Gallop MR, Flores Ramos S, Zarrinpar A, Broussard JL, Chondronikola M, Chaix A, Klein S. Complex physiology and clinical implications of time-restricted eating. Physiol Rev. 2022 Oct 1;102(4):1991-2034. doi: 10.1152/physrev.00006.2022. Epub 2022 Jul 14.

    PubMed 35834774

  • Chaix A, Manoogian ENC, Melkani GC, Panda S. Time-Restricted Eating to Prevent and Manage Chronic Metabolic Diseases. Annu Rev Nutr. 2019 Aug 21;39:291-315. doi: 10.1146/annurev-nutr-082018-124320. Epub 2019 Jun 10.

    PubMed 31180809

  • Downer S, Berkowitz SA, Harlan TS, Olstad DL, Mozaffarian D. Food is medicine: actions to integrate food and nutrition into healthcare. BMJ. 2020 Jun 29;369:m2482. doi: 10.1136/bmj.m2482.

    PubMed 32601089

  • Playdon M, Rogers TN, Brooks E, Petersen EM, Tavake-Pasi F, Lopez JA, Quintana X, Aitaoto N, Rogers CR. Sociocultural influences on dietary behavior and meal timing among Native Hawaiian and Pacific Islander women at risk of endometrial cancer: a qualitative investigation. Cancer Causes Control. 2023 Jan;34(1):23-37. doi: 10.1007/s10552-022-01628-0. Epub 2022 Oct 8.

    PubMed 36208351

  • Bidonde J, Fagerlund BC, Fronsdal KB, Lund UH, Robberstad B. FreeStyle Libre Flash Glucose Self-Monitoring System: A Single-Technology Assessment [Internet]. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2017 Aug 21. Report from the Norwegian Institute of Public Health No. 2017-07. Available from http://www.ncbi.nlm.nih.gov/books/NBK482068/

    PubMed 29553668

  • Muniyappa R, Madan R, Varghese RT. Assessing Insulin Sensitivity and Resistance in Humans. 2024 Oct 16. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK278954/

    PubMed 25905189

Questions about this trial

What is this clinical trial studying?

A study testing Time Restricted Eating (TRE) and Medically Tailored Meals (MTM) in people with Cancer Prevention, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient metabolic kitchen support). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of women recruited/consented - Feasibility (time frame: From enrollment to the 6-month follow up survey.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07262593, which also lists 169 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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