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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Obese older adults will be randomized to participate in either healthy lifestyle intervention or behavioral diet and exercise intervention for one year. This study aims to determine the effects of Lifestyle intervention on bone microarchitecture, bone strength, bone material properties, and the mechanism behind it.

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 the Healthy Lifestyle Intervention generally safe for humans?

The research suggests that lifestyle interventions, which include changes in diet and physical activity, are generally safe for humans. These interventions have been studied in various settings and have shown health benefits, although not all participants achieve significant weight loss. ^{1 2 3 4 5}

How is the Healthy Lifestyle Intervention treatment for bone health different from other treatments?

The Healthy Lifestyle Intervention treatment is unique because it focuses on improving bone health through lifestyle changes like diet and physical activity, rather than using medications. This approach is similar to interventions used for weight loss and cardiovascular health, emphasizing behavior change and counseling to promote long-term health improvements. ^{3 4 6 7 8}

What data supports the effectiveness of the treatment Healthy Lifestyle Intervention for Bone Health?

Research shows that lifestyle interventions, including dietary counseling and physical activity, can improve health outcomes in conditions like obesity and type 2 diabetes. These interventions help people adopt healthier behaviors, which can also benefit bone health. ^{2 7 8 9 10}

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.

I have osteoporosis or have had fractures from minor injuries.

I do not have major health or psychiatric issues that would stop me from joining an exercise program.

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. [2022]

2. England 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Telephone interventions for physical activity and dietary behavior change: a systematic review. [2022]

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

Psychotherapy for health and lifestyle change. [2004]

5. Finland pubmed.ncbi.nlm.nih.gov

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

6. Canada pubmed.ncbi.nlm.nih.gov

The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. [2019]

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

Primary care delivery of behavioral weight loss services for adults with cardiovascular risk factors: development of pragmatic practice components and results of a randomized feasibility trial. [2023]

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

Primary care delivery of behavioral weight loss services for adults with cardiovascular risk factors: development of pragmatic implementation strategies and results of a randomized feasibility trial. [2023]

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

Lifestyle-Based Obesity Care. [2023]

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

Counseling patients for lifestyle change: making a 15-minute office visit work. [2015]