NCT02960542

Brief Summary

This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

October 31, 2016

Last Update Submit

June 18, 2020

Conditions

ObesityCancer

Keywords

lifestyle interventionweight-loss

Outcome Measures

Primary Outcomes (3)

  • Recruitment of 20 eligible study participants

    Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)

    6 months

  • Retention of study participants

    Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)

    6 months

  • Attendance at group sessions

    Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)

    6 months

Secondary Outcomes (5)

  • Blood Pressure

    6 months

  • Weight

    6 months

  • Glucose

    6 months

  • Insulin

    6 months

  • Cholesterol

    6 months

Study Arms (1)

Lifestyle Weight Loss

EXPERIMENTAL

The Behavioral: HELP Prevent Cancer Intervention is a lifestyle intervention consisting of 24-weekly group meetings led by a community health worker and 3 individual sessions with a nutritionist/diabetes educator

Behavioral: HELP Prevent Cancer Intervention

Interventions

HELP Prevent Cancer InterventionBEHAVIORAL

This Behavioral: Lifestyle Weigh Loss Intervention involves a dietary weight-loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight-loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight-loss of .3 kg/week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 minutes/week.

Lifestyle Weight Loss

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials.
  • Body Mass Index: BMI \> 25 kg/m2.

You may not qualify if:

  • Weight Loss: Currently involved in a supervised program for weight loss.
  • Medications: Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids).
  • Recent History of Cardiovascular Disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure.
  • Hypertension: Uncontrolled high blood pressure: BP \> 160/100. Persons can be re-screened after controlled.
  • Pregnancy: Pregnancy, breast feeding, or planning pregnancy within 1 year.
  • Other Chronic Conditions: Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Related Publications (1)

  • Wise Thomas S, Blackwell Young C, Zoellner J, Brock DP, Isom S, Vitolins M. Feasibility of an Adapted Community-Based Lifestyle Intervention to Prevent Cancer in the Rural South: Healthy Living Partnerships to Prevent Cancer (HELP PC). J Cancer Educ. 2023 Apr;38(2):440-447. doi: 10.1007/s13187-022-02137-z. Epub 2022 Jan 25.

    PMID: 35076863DERIVED

MeSH Terms

Conditions

ObesityNeoplasmsWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Mara Z Vitolins, DrPH MPH RDN

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 9, 2016

Study Start

June 26, 2017

Primary Completion

April 4, 2018

Study Completion

April 4, 2018

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)