Nutrition and Exercise Instruction for Weight Changes

(CAM Trial)

Overseen By Andrea Myers, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nell Blake, DPM

Disqualifiers: Pregnancy, Vertigo, Balance issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on nutrition and exercise, so it's unlikely that your medications will be affected, but you should confirm with the trial organizers.

Is Nutrition and Exercise Instruction generally safe for humans?

Nutrition and exercise instruction, which involves making small, sustainable changes to diet and physical activity, is generally considered safe for humans. Studies have shown that these interventions can lead to positive changes in dietary behavior and help prevent weight gain without significant safety concerns. ^{1 2 3 4 5}

How does the Nutrition and Exercise Instruction treatment differ from other weight management treatments?

This treatment is unique because it combines both nutrition education and exercise instruction, emphasizing a balanced approach to weight management. Unlike treatments that focus solely on diet or exercise, this approach aims to improve dietary compliance and promote weight loss by integrating both components, potentially leading to more consistent and sustainable results. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Nutrition and Exercise Instruction for weight changes?

Research shows that combining nutrition education with physical activity can lead to significant weight loss and help maintain weight loss over time. This approach is more effective than exercise alone and can improve health by reducing obesity-related risks. ^{7 10 11 12 13}

Who Is on the Research Team?

Nell Blake, DPM

Principal Investigator

Penn State Health Hershey Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a foot or ankle injury who are prescribed a CAM boot. They must understand the study, be willing to have their height and weight measured, consent voluntarily, and speak English fluently. Pregnant women, those under 18, individuals with balance issues or unable to consent or follow the study's exercise and nutrition guidelines cannot participate.

Inclusion Criteria

Participants willing to have height and weight measured at the time of enrollment and final visit

Participant is able to provide voluntary, written consent

Fluent in written and spoken English

Exclusion Criteria

I am under 18 years old.

Pregnant women

I experience vertigo or have balance problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a CAM boot and may receive nutritional guidelines and upper body exercise instructions

12 weeks

Height and weight recorded at enrollment and final visit

Follow-up

Participants are monitored for weight change and effectiveness of the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition and Exercise Instruction

Trial Overview The study aims to see if wearing a CAM boot affects weight change when combined with nutritional advice and upper body exercises compared to just wearing the boot without additional guidance.

How Is the Trial Designed?

Group I: Nutrition and Exercise Instruction Active Control 1 Intervention

CAM prescribed as standard of care. Nutritional guidelines provided and upper body exercise instructions provided. Height and weight recorded at enrollment and final visit. Subjects in this group will undergo a follow up interview that will ultimately be used to examine and assess the helpfulness of the intervention in preventing weight for CAM boot wearing patients.

Group II: Standard of Care Active Control 1 Intervention

CAM boot prescribed as standard of care. No nutritional guidelines or upper body exercises instructions provided. Height and weight recorded at enrollment and final visit.

Who Is Running the Clinical Trial?

Nell Blake, DPM

Lead Sponsor

Trials

2

Recruited

70+

Milton S. Hershey Medical Center

Collaborator

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

A performance improvement process in a 28-bed ICU led to better patient outcomes by increasing the use of enteral nutrition over parenteral nutrition and starting nutrition support sooner.

The implementation of educational programs and a systematic approach resulted in meeting patients' protein and energy needs, ultimately enhancing nutrition support practices and achieving cost savings for the community hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced enteral and parenteral nutrition practice and outcomes in an intensive care unit with a hospital-wide performance improvement process. Schwartz, DB.[2019]

Personalized nutritional support is crucial for improving patient outcomes, as it can influence therapeutic interventions, hospitalization duration, and overall prognosis.

Regular assessments of each patient's caloric needs and respiratory quotient are essential to tailor nutritional treatments effectively, helping to avoid complications from both overfeeding and underfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Individualized energy metabolic monitoring and its clinical application]. Wang, P., Guo, Q., Li, Y.[2006]

Effective nutrition education for adults involves a structured three-phase approach: assessment, intervention, and evaluation, which is crucial for addressing various health issues like weight reduction and diabetes.

Maintaining behavioral changes post-education is a significant challenge, highlighting the need for well-trained nutrition education providers and effective strategies to support long-term adherence to dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education for risk factor reduction and patient education: a review. Glanz, K.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Group approach to weight control: behavior modification, nutrition, and health education. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Enhanced enteral and parenteral nutrition practice and outcomes in an intensive care unit with a hospital-wide performance improvement process. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Corrigendum. [2015]

4. Austria pubmed.ncbi.nlm.nih.gov

[Diet and physical activity in the treatment of obesity]. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Individualized energy metabolic monitoring and its clinical application]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluating a small change approach to preventing long term weight gain in overweight and obese adults--Study rationale, design, and methods. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

1985 NHIS findings: nutrition knowledge and baseline data for the weight-loss objectives. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Reproducibility of 24-h post-exercise changes in energy intake in overweight and obese women using current methodology. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Nutrition education for risk factor reduction and patient education: a review. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Positive effect of a nutrition instruction model on the dietary behavior of a selected group of elderly. [2019]

11. South Africa pubmed.ncbi.nlm.nih.gov

Weight loss in obese women--exercise v. dietary education. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Nutritional Therapy. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Nutrition and Physical Activity Interventions Provided by Nutrition and Exercise Practitioners for the General Population: An Evidence-Based Practice Guideline From the Academy of Nutrition and Dietetics and American Council on Exercise. [2023]