Online Training for Obesity Prevention

Overseen By Debra M Rios, DrPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: ISA Associates, Inc.

Disqualifiers: Male, Pregnant, others

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

Compensation: Varies

Number of Visits: 3

124 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test a new web-based promotora de salud/ community health worker (CHW) training. This training is designed to provide CHWs with the knowledge and skills to effectively implement a healthy living intervention for Latinas. The main question it aims to answer is: o Do CHWs who complete the web-based healthy living training have higher self-efficacy in implementing core lifestyle intervention learning components for obesity interventions in Hispanics than CHWs who do not? Participants will: * Complete a baseline survey asking about self-efficacy related to implementing core lifestyle intervention learning components, knowledge, health behaviors, and skill mastery. * Be randomized to receive the new web-based training or to a standard CHW training designed by Health and Human Services. The new web-based training provides promotores with the self-efficacy, knowledge, and skills required to effectively implement an obesity intervention for Hispanic women. Promotores will build their skillset through interactive quizzes, exercises, video role-playing scenarios, and interactive tools. * Complete follow-up surveys at 3 months and 6 months after the baseline survey. This survey will ask the same questions as the baseline survey and will include additional questions regarding satisfaction with training and behavior application. Researchers will compare participants who receive the new web-based training to participants who utilize the HHS training. The goal is to see whether the new web-based training increases self-efficacy among CHWs to effectively implement core lifestyle learning components for obesity interventions in Hispanics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on training community health workers, so it's unlikely to require changes to your medication.

What data supports the effectiveness of the treatment Comadres Saludables for obesity prevention?

Research shows that online and mobile-based weight-loss interventions can be effective, especially when they include behavioral components and professional coaching, as seen in studies where similar methods led to weight loss in participants. ^{1 2 3 4 5}

Is the Online Training for Obesity Prevention generally safe for humans?

The research articles provided do not contain specific safety data for the Online Training for Obesity Prevention or related interventions like Comadres Saludables, Control, Placebo, or Standard Care. Therefore, no relevant safety information is available from these sources. ^{4 6 7 8 9}

How is the Comadres Saludables treatment for obesity prevention unique?

Comadres Saludables is unique because it is an online training program designed to prevent obesity, making it more accessible and potentially more cost-effective than traditional in-person treatments. This approach can reach a larger audience and promote healthy lifestyle changes through the internet. ^{1 10 11 12 13}

Research Team

Debra M Rios, DrPH

Principal Investigator

ISA Associates

Eligibility Criteria

This trial is for female community health workers over 18, comfortable with English or Spanish, who have internet access and serve Hispanic communities. They must either be certified in Texas or have over six months of experience. Pregnant women and males are excluded.

Inclusion Criteria

Access to a computer that has internet

Not Pregnant

Have a community health worker certification through the state of TX OR have worked over 6 months as a community health worker and meet core competencies for CHWs

Exclusion Criteria

Does not provide services to Hispanic populations

Pregnant

Does not have a community health worker certification through the state of TX OR have not worked over 6 months as a community health worker and do not meet core competencies for CHWs

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey assessing self-efficacy, knowledge, health behaviors, and skill mastery

1 week

1 visit (virtual)

Training

Participants are randomized to receive either the new web-based training or the standard HHS training for three months

12 weeks

Ongoing virtual access

Follow-up

Participants complete follow-up surveys at 3 months and 6 months after the baseline survey to assess self-efficacy, behavior application, and satisfaction with training

12 weeks

2 visits (virtual)

Treatment Details

Interventions

• Comadres Saludables
• Control

Trial Overview The study tests a new web-based training against standard training to see if it better equips community health workers with the skills to implement obesity interventions for Hispanic women. It measures self-efficacy, knowledge, and skill application through surveys.

Participant Groups

Group I: Web-based Comadres Saludables CHW Training Experimental Treatment 1 Intervention

Experimental group participants will have access to the web-based Comadres Saludables training for three months.

Group II: HHS Promoting Healthy Choices and Community Changes Active Control 1 Intervention

Control condition participants will receive information on how to access the HHS CHW Promoting Healthy Choices and Community Changes training. They will be asked to review for three months.

Who Is Running the Clinical Trial?

ISA Associates, Inc.

Lead Sponsor

Trials

6

Recruited

920+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

A one-month lifestyle intervention using the LoseIt! app led to significant weight loss in overweight/obese cancer survivors, with participants losing an average of 6.4 kg and showing reductions in BMI and waist circumference.

The intervention improved participants' self-efficacy regarding weight management, as indicated by a significant increase in the Weight Efficacy Lifestyle Questionnaire score, demonstrating the app's effectiveness in promoting healthier lifestyle choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. McCarroll, ML., Armbruster, S., Pohle-Krauza, RJ., et al.[2022]

A fully automated online behavioral weight-loss intervention offered to 1,721 patients in a primary care setting resulted in a significant average weight loss of 5.10% over 12 weeks, demonstrating its efficacy without the need for face-to-face counseling.

Engagement in the program was crucial; patients who consistently submitted their weights for all 12 weeks lost an average of 7.2% of their body weight, highlighting the importance of participation in achieving better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic implementation of a fully automated online obesity treatment in primary care. Thomas, JG., Panza, E., Espel-Huynh, HM., et al.[2023]

In a study involving 577 patients from 18 clinics, researcher-measured body weights and electronic medical record (EMR)-derived weights showed a very high correlation (0.988), indicating that both methods are reliable for tracking weight changes over time.

However, the weight loss observed in the intensive lifestyle intervention (ILI) group was significantly lower when measured using EMR data compared to researcher measurements, suggesting that studies relying on EMR data may need larger sample sizes to accurately detect weight loss effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial. Katzmarzyk, PT., Mire, EF., Martin, CK., et al.[2022]

A study involving 828 participants identified three distinct user classes based on baseline health habits and early platform use, which were linked to long-term adherence to a weight loss program.

While class membership influenced adherence, it did not significantly affect weight loss outcomes; however, users with better habits who received coaching lost more weight than those without coaching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Baseline User Characteristics and Early Use Patterns (24-Hour) on Long-Term Adherence and Effectiveness of a Web-Based Weight Loss Randomized Controlled Trial: Latent Profile Analysis. Andrade, AQ., Beleigoli, A., Diniz, MF., et al.[2021]

In a 12-week study involving 112 overweight Japanese adults, those receiving professional dietary coaching via a smartphone app lost significantly more weight (average -1.4 kg) compared to the control group (-0.1 kg).

Participants who frequently uploaded meal photos to the group chat not only lost more weight but also showed significant improvements in cardiometabolic risk factors, indicating that active engagement in the program enhances health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. Tanaka, K., Sasai, H., Wakaba, K., et al.[2022]

In a review of 24 large randomized controlled trials on weight loss medications, total participant dropout rates were significantly influenced by the type of treatment, with placebo and certain medications showing higher attrition rates.

Implementing a pre-randomization lead-in period was associated with lower dropout rates (29.1% vs. 39.9%), and studies with a higher percentage of female participants also experienced greater attrition, indicating that study design and participant demographics are crucial for improving retention in obesity trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. Fabricatore, AN., Wadden, TA., Moore, RH., et al.[2022]

A technology-based weight loss intervention for 18 urban, low-income mothers resulted in a significant weight loss of -2.9 kg over 14 weeks, compared to only 0.5 kg in the usual care group, indicating its efficacy.

One-third of the mothers in the intervention group lost more than 5% of their initial body weight, highlighting the potential of technology to support weight loss in postpartum women from disadvantaged backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using technology to promote postpartum weight loss in urban, low-income mothers: a pilot randomized controlled trial. Herring, SJ., Cruice, JF., Bennett, GG., et al.[2022]

Obesity reduction medication use among insured individuals in the U.S. significantly decreased from 1% in 2002 to 0.7% in 2005, particularly for newer medications like orlistat and sibutramine.

Only a small percentage (11-18%) of users continued these medications for longer than 3 months, highlighting potential issues with long-term adherence and the need for prescribers to consider contraindications and patient screening for related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in and patterns of obesity reduction medication use in an insured cohort. Bolen, SD., Clark, JM., Richards, TM., et al.[2021]

In a 6-month double-blind study involving 61 obese patients, sibutramine led to a significant weight loss of 7.3 kg (8% of initial weight) compared to only 2.6 kg (2.8%) in the placebo group, demonstrating its efficacy in managing obesity.

Sibutramine was well-tolerated, with side effects not leading to treatment discontinuation, although it did result in a slight increase in systolic blood pressure (5 mmHg).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. Halpern, A., Leite, CC., Herszkowicz, N., et al.[2019]

This study is a randomized controlled trial involving Brazilian adults aged 18-60 with a BMI of 25 or higher, aiming to evaluate the effectiveness of a web-based platform for promoting weight loss and healthier lifestyle changes over 12 and 24 weeks.

Participants will be divided into three groups: a waitlist with minimal intervention, a web-based platform, and a web-based platform with online dietician support, allowing researchers to assess the impact of different levels of online assistance on weight loss and behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online platform for healthy weight loss in adults with overweight and obesity - the "POEmaS" project: a randomized controlled trial. Beleigoli, AM., Queiroz de Andrade, A., Haueisen Diniz, MF., et al.[2019]

A randomized controlled trial involving 80 overweight/obese women showed that both a skill-based intervention (SBI) and counseling-based intervention (CBI) led to significant weight loss at 6 months, with participants maintaining some weight loss at 24 months.

The SBI group demonstrated a significant reduction in dietary fat intake, suggesting that this intervention may positively influence eating habits, although the long-term weight loss differences between SBI and CBI were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical skills for weight loss: 2-y follow-up results of a randomized trial. Yeh, MC., Rodriguez, E., Nawaz, H., et al.[2016]

Out of 172 families that enrolled in the study aimed at training moderately overweight youths, only 38 children (22.1%) were actually eligible due to being classified as overweight, while the majority (76.7%) were obese.

The recruitment strategies, including media exposure and pediatrician referrals, were more effective for reaching obese children, highlighting a challenge in identifying and engaging moderately overweight youths for intervention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overweight children and adolescents--is there a subjective need for treatment? Finne, E., Reinehr, T., Schaefer, A., et al.[2009]

The internet-based obesity prevention program significantly reduced the percentage of overweight and obese children in the intervention group (39.6%) compared to the control group (56.6%) after four months, indicating its efficacy in promoting healthier weight status.

Children in the intervention group experienced a smaller increase in BMI (0.40 kg/m²) compared to the control group (1.24 kg/m²), demonstrating that the program effectively helped maintain healthier body weight among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet Based Obesity Prevention Program for Thai School Children- A Randomized Control Trial. Rerksuppaphol, L., Rerksuppaphol, S.[2020]

References

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

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. [2022]

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

Pragmatic implementation of a fully automated online obesity treatment in primary care. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Influence of Baseline User Characteristics and Early Use Patterns (24-Hour) on Long-Term Adherence and Effectiveness of a Web-Based Weight Loss Randomized Controlled Trial: Latent Profile Analysis. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. [2022]

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

Using technology to promote postpartum weight loss in urban, low-income mothers: a pilot randomized controlled trial. [2022]

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

Trends in and patterns of obesity reduction medication use in an insured cohort. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of efficacy, reliability, and tolerability of sibutramine in obese patients, with an echocardiographic study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Online platform for healthy weight loss in adults with overweight and obesity - the "POEmaS" project: a randomized controlled trial. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Technical skills for weight loss: 2-y follow-up results of a randomized trial. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Overweight children and adolescents--is there a subjective need for treatment? [2009]

13. India pubmed.ncbi.nlm.nih.gov

Internet Based Obesity Prevention Program for Thai School Children- A Randomized Control Trial. [2020]