Clinical trial

Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02774759

Active, not recruitingNot applicableInterventional

What this study is about

The goal of this research study is to learn if a home-based physical activity program is feasible and can help endometrial cancer survivors lose weight.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionMalignant Neoplasms of Female Genital Organs

Full registry criteria

Inclusion Criteria: 1. Diagnosed with Stage I-II endometrial cancer 2. Six to 36 months post treatment 3. Body mass index (BMI) 30-\<45 kg/m2 4. Age of at least 18 years 5. Access to a telephone for coaching sessions and access to a computer, smartphone, or tablet for syncing Fitbit devices 6. Can speak and read English 7. Can provide informed consent 8. Willing to travel to MD Anderson's main campus for 2 visits (baseline and 6 months post-baseline) Exclusion Criteria: 1. Unmanaged lymphedema 2. Medical contraindications to home-based exercise or low-fat, high fruit and vegetable diet 3. Functional limitations requiring a walker/scooter/wheelchair for daily activities 4. Recurrent disease 5. Vigorous exercise \> or = 60 min/week or moderate exercise \> or = 150 min/week. If a combination of moderate and vigorous exercise are preformed, the minutes of moderate exercise/week plus 2 x minutes of vigorous exercise/week \> or = 150 min/week. 6. Resistance training on \> or = 2 days/week accounting for more than 30 minutes of strength training per week 7. Enrollment in a structured weight loss program in the past 6 months

Treatments and study arms

Accelerometer

Device

Participant wears an accelerometer for 7 days before baseline visit to record activity levels, and again before their 6 month visit.

Questionnaires

Behavioral

Questionnaires completed at baseline regarding quality of life and diet. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc.

Fitness Test

Behavioral

Fitness test given covering various physical activities at baseline and at 6 month visit.

Resistance Training

Behavioral

Physical activity guidelines workbook distributed along with activity monitor. Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member. Information from wireless scale and Fitbit sent to Fitbit website to monitor levels.

Aerobic Exercise

Behavioral

Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor.

Telephone Coaching/Phone Calls

Behavioral

Participants called 4 times during the first month, 2 times during the second month, and 1 time per month for the rest of the study. Participants also receive a follow-up call at the end of the study.

Video Chat Sessions

Behavioral

Video chatting between the research team and participants occurs 2 times per month during the first and third months, when new exercises are introduced. Video chatting offered monthly as needed by participants during months 2, 4, 5, and 6.

Primary outcomes

Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors6 months

Study considered feasible if consent rate is larger than 40%.

Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors6 Months

Study considered feasible if retention rate is larger than 70%.

Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors6 months

Study considered feasible if adherence in NEXT Steps- Aerobic exercise and Resistance Training (NS-ART) and NEXT Steps- Aerobic exercise (NS-A) is larger than 65%.

Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors6 months

Study considered feasible if the mean overall satisfaction with the program is larger than 3.5 in a 5-level scale.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Texas MD Anderson Cancer Center🇺🇸 Houston, Texas, United States

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