Healthy Lifestyle Intervention for Bone Health

(LIMB-Q Trial)

Overseen By Belen Segoviano-Escobar, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Bone drugs, Insulin

Disqualifiers: Cardiopulmonary, Orthopedic, Neuromuscular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how different lifestyle changes can improve bone health in older adults who are overweight. Participants will either focus on weight loss with exercise or attend group sessions about diet, exercise, and social support for one year. The goal is to assess how these lifestyle changes affect bone strength and quality. The trial seeks individuals aged 65 to 85 who are obese, have maintained a stable weight recently, and have not been exercising regularly. As an unphased trial, this study provides a unique opportunity to contribute to valuable research on lifestyle changes and bone health.

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

The trial requires that you do not use certain bone-acting drugs, like estrogen or bisphosphonates, and weight loss drugs. If you're on these, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changes in diet and exercise are generally safe and can improve bone health without causing harm. For instance, they can maintain bone quality in older adults, even if some bone loss occurs due to weight loss. One study found that lifestyle changes can enhance bone health in postmenopausal women.

Most people handle these lifestyle changes well, with few reports of negative effects. These changes often include group sessions that provide support and education about diet and exercise. Overall, evidence suggests that these changes are a safe way to improve bone health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle interventions for bone health because they focus on holistic changes rather than medication. Unlike traditional treatments like calcium or vitamin D supplements, these interventions emphasize behavioral therapy for weight loss, exercise training, and group education sessions that promote diet and social support. By addressing lifestyle factors, these interventions could potentially improve bone health naturally and sustainably, offering a fresh approach to bone health management.

What evidence suggests that this trial's interventions could be effective for bone health?

Research has shown that lifestyle changes, such as healthier eating and increased exercise, can improve bone health. In this trial, participants will join one of two groups: the Lifestyle Intervention Group, which includes behavioral therapy for weight loss and exercise training, or the Healthy Lifestyle Intervention Group, which offers group education sessions on diet, exercise, and social support. For instance, one study found that these changes helped postmenopausal women achieve healthier bones. Another study demonstrated that lifestyle changes could also improve conditions like obesity, which can impact bone health. However, these changes might sometimes lead to a greater loss of bone strength in the hip, weakening bones in that area. Overall, focusing on diet and exercise benefits bone health, but caution is necessary to avoid potential downsides. ^{1 2 6 7 8}

Who Is on the Research Team?

Dennis T Villareal, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for obese older adults aged 65-85 with a BMI of 30-40 who are sedentary and have had a stable body weight in the last six months. It's not for those with osteoporosis, severe diseases that limit exercise, cognitive impairments, uncontrolled hypertension, recent cancer (except skin), or on certain medications.

Inclusion Criteria

Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months)

Stable body weight (±2 kg) during the past 6 months

BMI 30 - 40 kg/m2

Exclusion Criteria

I do not have severe heart or lung conditions that would prevent me from exercising or dieting.

Positive exercise stress test for ischemia

I have osteoporosis or have had fractures from minor injuries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a healthy lifestyle intervention or a behavioral diet and exercise intervention for one year

52 weeks

Follow-up

Participants are monitored for changes in bone quality, strength, and other health metrics after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Lifestyle Intervention
• Lifestyle Intervention

Trial Overview

The study compares two groups: one follows a healthy lifestyle intervention while the other engages in both diet and exercise changes for one year. The goal is to see how these interventions affect bone strength and quality in aging individuals.

How Is the Trial Designed?

Group I: Lifestyle intervention Group Experimental Treatment 1 Intervention

Behavioral therapy for weight loss and Exercise Training

Group II: Healthy lifestyle intervention Group Active Control 1 Intervention

Group education sessions that focus on diet exercise and social support.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Michael E. DeBakey VA Medical Center

Collaborator

Trials

68

Recruited

17,200+

Biomedical Research Institute of New Mexico

Collaborator

Trials

11

Recruited

2,300+

Published Research Related to This Trial

Lifestyle interventions can lead to weight loss and health benefits, as shown in large randomized clinical trials, but not all participants achieve even a 5% reduction in body weight, and weight regain is a common issue.

Real-world studies show only modest weight loss from lifestyle changes, and there is currently no reimbursement model to support these interventions in medical office settings, highlighting the need for healthcare providers to understand both the potential and limitations of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle-Based Obesity Care. Ryan, DH.[2023]

Many people struggle to follow dietary and exercise recommendations, indicating that current lifestyle counseling may not be effectively reaching its goals, despite being considered essential in medical care.

Research suggests that both conscious and automatic psychosocial processes can support behavior change, and there is growing evidence that automated processes may enhance the effectiveness of lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to help patients adopt and maintain a healthy lifestyle? A review of behavioral evidence of determinants and means. Absetz, P., Hankonen, N.[2018]

Lifestyle counseling is effective in managing chronic diseases and improving satisfaction for both patients and providers, but challenges remain in implementing and maintaining these changes.

The case study demonstrates that motivational interviewing can be a practical strategy used during office visits to help patients identify and achieve their health goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling patients for lifestyle change: making a 15-minute office visit work. Berra, K., Hughes, S.[2015]

The article reviews four evidence-based models for facilitating health or lifestyle changes: the Transtheoretical Model, Brief Motivational Interviewing, Prevention Oriented Primary Care, and the ECBIS Psychotherapy Model, highlighting their systematic and integrative approaches.

These models can be effectively combined in clinical practice to assist patients in changing multiple health behaviors, demonstrating their practical application in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for health and lifestyle change. Feinstein, RE., Feinstein, MS.[2004]

The LINDA intervention, which provided individualized lifestyle counseling to 1,537 young women over 1.5-2.5 years, resulted in a 37% improvement in health behaviors related to physical activity, meal regularity, and sleep compared to 31% in the control group.

Participants who received targeted support for physical activity and sleep showed significant improvements, with 30% increasing their activity levels and 36% going to bed earlier, indicating the effectiveness of personalized counseling in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LINDA - a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. Valve, P., Lehtinen-Jacks, S., Eriksson, T., et al.[2021]

The Electronic Cardio-Metabolic Program (eCMP) was found to be a feasible and well-accepted intervention for high-risk adults, with a high retention rate of 93% at 3 months and 86% at 6 months.

Participants in the eCMP experienced significant weight loss and reductions in waist circumference, along with decreased anxiety and perceived stress, indicating potential benefits in cardiometabolic risk factors despite no significant change in overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. Azar, KM., Koliwad, S., Poon, T., et al.[2019]

A systematic review of 26 studies found that telephone counseling interventions for physical activity and dietary behavior change are effective, with 20 out of 26 studies reporting significant improvements in behavior.

Interventions lasting 6 to 12 months and involving 12 or more calls were associated with the most favorable outcomes, highlighting the importance of duration and frequency in achieving positive behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone interventions for physical activity and dietary behavior change: a systematic review. Eakin, EG., Lawler, SP., Vandelanotte, C., et al.[2022]

Both in-person and telephone group lifestyle interventions (LI) led to significantly greater weight loss compared to medical nutrition therapy (MNT) in patients with type 2 diabetes, with mean weight loss of 5.6% and 4.6% respectively at 6 months.

The cost-effectiveness of in-person LI was better than telephone LI, with an incremental cost of $789 per kilogram lost compared to $1223 for telephone LI, indicating that in-person programs may provide a more economical option for achieving weight loss in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. Delahanty, LM., Levy, DE., Chang, Y., et al.[2022]

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