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

NCT07262593 | Terminated DMC

• 1 other identifier: HCI166790
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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

Cancer Prevention

Keywords

Diet; Time Restricted Eating; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment to the 6 month follow up survey

Secondary Outcomes (26)

• Attrition - Feasibility

  From enrollment to the 6 month follow up survey

• Study Procedures Completed - Feasibility

  From enrollment to the 6 month follow up survey

• TRE Adherent Days - Feasibility

  From enrollment to the 6 month follow up survey

• Meals Delivered - Feasibility

  From enrollment to the 6 month follow up survey

• Protocol Items Delivered as Intended - Fidelity

  From enrollment to the 6 month follow up survey

Study Arms (4)

Control

NO INTERVENTION

Participants will continue their usual lifestyle.

Time Restricted Eating (TRE)

EXPERIMENTAL

Participants will complete the TRE schedule for 8 weeks.

Other: Time Restricted Eating (TRE)

Medically Tailored Meals (MTM)

EXPERIMENTAL

Participants will be given MTM for 8 weeks.

Other: Medically Tailored Meals (MTM)

Time Restricted Eating (TRE) + Medically Tailored Meals (MTM)

EXPERIMENTAL

Participants will complete the TRE schedule and be given MTM for 8 weeks.

Other: Time Restricted Eating (TRE); Other: Medically Tailored Meals (MTM)

Interventions

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.

Time Restricted Eating (TRE); Time Restricted Eating (TRE) + Medically Tailored Meals (MTM)

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.

Medically Tailored Meals (MTM); Time Restricted Eating (TRE) + Medically Tailored Meals (MTM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

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MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Mary Playdon, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants received isocaloric, culturally tailored, pre-prepared meals to control underlying diet during TRE and control

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: December 3, 2025
• Study Start: October 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)