120 Participants Needed

Healthy Lifestyle Intervention for Bone Health

(LIMB-Q Trial)

DT
BS
Overseen ByBelen Segoviano-Escobar, MS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.36789

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.247810

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.

Research Team

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Dennis T Villareal, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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
See 2 more

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.
See 12 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle intervention GroupExperimental Treatment1 Intervention
Behavioral therapy for weight loss and Exercise Training
Group II: Healthy lifestyle intervention GroupActive Control1 Intervention
Group education sessions that focus on diet exercise and social support.

Find a Clinic Near You

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+

Findings from Research

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

References

Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. [2022]
LINDA - a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. [2021]
Telephone interventions for physical activity and dietary behavior change: a systematic review. [2022]
Psychotherapy for health and lifestyle change. [2004]
How to help patients adopt and maintain a healthy lifestyle? A review of behavioral evidence of determinants and means. [2018]
The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. [2019]
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]
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]
Lifestyle-Based Obesity Care. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Counseling patients for lifestyle change: making a 15-minute office visit work. [2015]
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