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Cancer Survivors for Obesity

Q: Are there any ongoing efforts to enroll participants for this particular trial?

As per the information on clinicaltrials.gov, this particular study is not currently accepting new participants. The trial was initially posted on January 1st, 2024 and was last updated on December 19th, 2023. However, it's worth noting that there are currently a total of 1136 other ongoing studies actively seeking patients at this time.

Q: Are individuals who are 25 years old and above eligible to participate in this medical study?

This research study is open to individuals who are at least 18 years old and below the age of 75.

Q: What is the primary objective that this medical study aims to achieve?

This study aims to evaluate the acceptability of the intervention by program delivery staff, utilizing AIM as a tool for assessment. Secondary outcomes include evaluating preliminary efficacy in terms of <a href="https://www.withpower.com/clinical-trials/weight-loss">weight loss</a>, which will be measured using digital scales. Additionally, the safety of the intervention will be assessed based on the number and severity of adverse events reported by participants during the study. Lastly, improvements in body composition will be evaluated using dual x-ray absorptiometry (DXA).

N/A

Recruiting

Led By Emily B Hill, PhD, RDN

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For intervention participants: Men and women, Age 18-75 years, BMI 25-45 kg/m2, Completion of active cancer therapy with curative intent at least three months and no more than five years prior to enrollment; ongoing hormone therapy is permitted, Have a primary care provider (or are willing to establish care with a primary care provider prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions and who will provide clearance to participate in a nutrition and exercise program, Ability and willingness to participate in a supervised exercise program; with ability assessed by the Physical Activity Readiness Questionnaire (PAR-Q+) and questions based upon National Comprehensive Cancer Network guidelines (note: any positive responses will trigger a required physician clearance form), Speak English, Have access to a computer or smart phone and Internet, Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects), Not be planning to travel for >2 consecutive weeks or relocate/move during the intervention, Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study, Capable and willing to give informed consent and understand exclusion criteria, Willing to attend weekly small group sessions (behavioral skills development and/or group support) and/or 1:1 counseling held by a registered dietitian (RD) and attend up to two BfitBwell exercise sessions per week, Not meeting dietary guidelines [i.e., Healthy Eating Index (HEI) score <80 as assessed via NCI DHQ III food frequency questionnaire] or physical activity guidelines

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test if it is possible and well-received to include a nutrition program for cancer survivors into an existing exercise program.

Who is the study for?

This trial is for individuals who are overweight or obese and have survived cancer. It's designed to see if a new nutrition program can work well alongside an existing exercise program made for cancer survivors.Check my eligibility

What is being tested?

The study is testing the integration of 'BfedBwell', which includes group-based nutritional education, cooking demos, and individual counseling, into the 'BfitBwell' clinical exercise program for cancer survivors.See study design

What are the potential side effects?

Since this trial focuses on nutrition and exercise interventions rather than medication, side effects may include muscle soreness from physical activity or changes in digestion due to diet adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the intervention acceptability by participants and program providers during qualitative interviews

Determine the intervention acceptability by participants using the Net Promoter Score (NPS)

Determine the intervention acceptability by program delivery staff using Acceptability of Intervention Measure (AIM)

+6 more

Secondary outcome measures

Assess preliminary efficacy for improvement in body composition

Assess preliminary efficacy for increased adherence to lifestyle recommendations

Assess preliminary efficacy for weight loss

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cancer SurvivorsExperimental Treatment4 Interventions

Cancer survivors with ow/ob who have completed active treatment will take part in a single-arm 12-week feasibility/acceptability/proof-of-concept study incorporating group nutrition education and discussion, skills development sessions and cooking demonstrations, and 1:1 counseling with a dietitian.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,491 Total Patients Enrolled

100 Trials studying Obesity

213,674 Patients Enrolled for Obesity

Emily B Hill, PhD, RDNPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

94 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this particular trial?

"As per the information on clinicaltrials.gov, this particular study is not currently accepting new participants. The trial was initially posted on January 1st, 2024 and was last updated on December 19th, 2023. However, it's worth noting that there are currently a total of 1136 other ongoing studies actively seeking patients at this time."

Answered by AI

Are individuals who are 25 years old and above eligible to participate in this medical study?

"This research study is open to individuals who are at least 18 years old and below the age of 75."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"This study aims to evaluate the acceptability of the intervention by program delivery staff, utilizing AIM as a tool for assessment. Secondary outcomes include evaluating preliminary efficacy in terms of weight loss, which will be measured using digital scales. Additionally, the safety of the intervention will be assessed based on the number and severity of adverse events reported by participants during the study. Lastly, improvements in body composition will be evaluated using dual x-ray absorptiometry (DXA)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BfedBwell Proof-of-Concept Pilot

2024. "BfedBwell Proof-of-Concept Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191666.

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