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

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding nutrition tips and arm exercises can help people wearing a CAM boot manage their weight better than wearing the boot alone. Participants will either follow a plan with nutritional advice and upper body exercises (referred to as Nutrition and Exercise Instruction) or continue with the boot as standard care. The study seeks adults with a foot or ankle injury who are using a CAM boot and are open to having their height and weight checked. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery strategies for future patients.

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.

What prior data suggests that this protocol is safe for patients wearing a CAM boot?

Research has shown that learning about nutrition and exercise is generally safe. Studies have found that making small, lasting changes to diet and physical activity can occur without major side effects. Exercise links to positive outcomes, such as weight loss and improved body shape, particularly in adults who are overweight or obese.

In short-term programs, combining exercise with nutrition advice has led to successful weight loss. Regular aerobic exercise has been associated with significant reductions in waist size and body fat. Reports of serious negative effects from these activities are absent.

Overall, evidence suggests that learning about nutrition and exercise is well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Exercise Instruction because it offers a proactive approach to managing weight changes for patients wearing a CAM boot, which is typically used for foot or ankle injuries. Unlike the standard of care that doesn't provide any nutritional or exercise guidance, this intervention includes tailored nutritional guidelines and upper body exercise instructions. This method aims to actively prevent unwanted weight gain during recovery, potentially improving overall patient outcomes and quality of life.

What evidence suggests that Nutrition and Exercise Instruction is effective for weight changes in CAM boot patients?

Research has shown that learning about nutrition and staying active can lead to significant weight loss and help maintain it over time. A review of 14 studies found that short-term programs, lasting six months or less, effectively promote weight loss. Another study suggested that combining a healthy diet with exercise results in more weight loss than exercise alone. Engaging in aerobic activities, like brisk walking or cycling, for at least 150 minutes a week, was linked to significant reductions in waist size and body fat. In this trial, participants in the "Nutrition and Exercise Instruction" arm will receive nutritional guidelines and upper body exercise instructions, which may help manage weight for people wearing a CAM boot. ^{2 4 5 6 7}

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

Pregnant women

Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations

I am under 18 years old.

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37084486/

A systematic review on the effectiveness of diet and ... The ADF participants achieved body weight change of mean -0.9% ± 0.6% in the low-weight-loss group, and -9.9% ± 1.1% in the high-weight-loss ...

2. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... This meta-analysis of 14 RCTs found that interventions lasting 6 months or less were effective at achieving weight loss. Each study showed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212267214010557

Diet or Exercise Interventions vs Combined Behavioral ... Our results indirectly suggest that the addition of diet to a physical activity intervention leads to more weight loss than the addition of physical activity to ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828487

Aerobic Exercise and Weight Loss in Adults: A Systematic ... Aerobic exercise at least 150 minutes per week was associated with clinically important reductions in waist circumference and measures of body fat.

5. withpower.com withpower.com/trial/nutrition-and-exercise-instruction-for-weight-changes-51615

Nutrition and Exercise Instruction for Weight Changes · Info ... Research shows that combining nutrition education with physical activity can lead to significant weight loss and help maintain weight loss over time. This ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8365736/

Effect of exercise training on weight loss, body composition ... These findings show favorable effects of exercise training on weight loss and body composition changes in adults with overweight or obesity. Visceral fat loss ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK221839/

Weight-Loss and Maintenance Strategies - NCBI - NIH The most important component of an effective weight-management program must be the prevention of unwanted weight gain from excess body fat.