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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01275 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0507 | Other Identifier | M D Anderson Cancer Center | |
| R21CA215415 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.
PRIMARY OBJECTIVES:
I. Determine the feasibility of adding hunger training to the Diabetes Prevention Program (DPP) using the following criteria: accrual rates > 50%, attrition rates < 20% and, in the DPP-plus-hunger training (HT) group, training protocol adherence rates > 75%.
SECONDARY OBJECTIVES:
I. Estimate the magnitude of effect sizes and variation in outcome variables for the DPP-only and DPP-plus-HT interventions on changes in weight; in metabolic and breast cancer risk biomarkers (e.g., fasting insulin and blood glucose [BG] levels, levels of glycosylated hemoglobin, insulin resistance, adiponectin, interleukin-6, and C-reactive protein); and in proposed behavioral mediators (e.g., reduction in total energy intake, overall eating frequency, percent of eating events occurring at or below the average fasting blood BG level).
II. Examine the mediation effects of proposed mechanisms of the interventions related to individual-level behavioral measures of eating self-regulation on the proposed outcomes using a multimodal approach of validated questionnaires and reliable ecological momentary assessment method.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Participants take part in DPP once a week over 1 hour for 16 weeks.
GROUP B: Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (DPP) | Active Comparator | Participants take part in DPP once a week over 1 hour for 16 weeks. |
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| Group B (DPP-HT) | Experimental | Participants take part in DPP once a week over 1 hour for 16 weeks and hunger training once a week during weeks 2-6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | Take part in DDP |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by recruitment rate | Measured by percentage of participants who enroll in the study. | Up to 2 years |
| Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by drop-out rates | Measured by percentage of participants who leave the study. | Up to 2 years |
| Feasibility of adding hunger training (HT) to Diabetes Prevention Program (DPP) as assessed by completion rates | Measured by percentage of participants who complete the study. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight loss | Will use linear regression to study the effects of participant characteristics (i.e., weight history) and their interactions with the treatment groups. | Baseline to 2 years |
| Changes in metabolic and breast cancer risk biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen M Basen-Engquist | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38660060 | Derived | Jospe MR, Liao Y, Giles ED, Hudson BI, Slingerland JM, Schembre SM. A low-glucose eating pattern is associated with improvements in glycemic variability among women at risk for postmenopausal breast cancer: an exploratory analysis. Front Nutr. 2024 Apr 10;11:1301427. doi: 10.3389/fnut.2024.1301427. eCollection 2024. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Behavioral, Psychological or Informational Intervention | Other | Take part in HT |
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| Questionnaire Administration | Other | Ancillary studies |
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Biomarkers will be assessed through blood draws. |
| Baseline to 2 years |
| Changes in proposed behavioral mediators through survey | Eating patterns will be assessed through survey ASA24 (Automated Self-assessment). | At baseline and at 16 weeks |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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