Nutrition and Exercise Instruction for Weight Changes
(CAM Trial)
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.12345Why 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.24567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants wear a CAM boot and may receive nutritional guidelines and upper body exercise instructions
Follow-up
Participants are monitored for weight change and effectiveness of the intervention
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?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nell Blake, DPM
Lead Sponsor
Milton S. Hershey Medical Center
Collaborator
Published Research Related to This Trial
Citations
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 ...
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 ...
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 ...
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.
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 ...
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 ...
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.
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