Wellness Coaching for Obesity

Overseen By Morgan Meyer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Weight loss medication

Disqualifiers: Type 1 diabetes, Cancer, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications. However, if you are currently using weight loss medication, you cannot participate in the trial.

What data supports the idea that Wellness Coaching for Obesity is an effective treatment?

The available research shows that community-based wellness coaching can be effective for weight loss. One study found that participants in a community-based weight-loss program achieved significant weight loss and maintained it over time, along with improvements in health and well-being. This suggests that wellness coaching can be a sustainable and effective treatment for obesity. ^{1 2 3 4 5}

What safety data exists for wellness coaching for obesity?

The available research on wellness coaching for obesity, including telephonic and web-based programs, does not specifically address safety data. However, these studies focus on the effectiveness of such programs in weight management and healthcare utilization. The evaluations indicate that these programs can achieve modest weight loss and do not report significant changes in healthcare utilization, suggesting no major safety concerns. Further research may be needed to explicitly assess safety outcomes. ^{1 6 7 8 9}

Is the Wellness Engagement Intervention a promising treatment for obesity?

Yes, the Wellness Engagement Intervention is a promising treatment for obesity. It uses community-based approaches, which have shown the ability to help many people lose weight. These programs are cost-effective and can reach people who might not seek professional help on their own. Community-based interventions can create lasting change by using local resources and addressing specific needs. ^{1 10 11 12 13}

Research Team

Moghboeba Mosavel, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for African American adults living in Petersburg, VA who are interested in community-based healthy lifestyle changes like walking and diet adjustments. Participants must be over 18 years old and not currently involved in other weight loss programs or using weight loss medications.

Inclusion Criteria

Resident of Petersburg, VA

I am willing to adopt healthy lifestyle changes like walking and eating better.

Exclusion Criteria

I am currently receiving treatment for cancer.

Inability to speak, read and write English

Planning to move from the Petersburg area within the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Wellness Ambassadors undergo training to recruit and deliver a lifestyle intervention

4 weeks

Intervention

Wellness Ambassadors deliver the lifestyle intervention to members of their social networks

12 weeks

Follow-up

Participants are monitored for feasibility and acceptability of the intervention

18 months

Treatment Details

Interventions

• Wellness Engagement Intervention

Trial Overview The study tests a Wellness Engagement Intervention through 'house chats' to promote weight management within the community. It aims to evaluate how feasible and acceptable this grassroots approach is for participants.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the intervention group will deliver the intervention immediately following baseline visits and randomization.

Group II: Delayed Intervention Active Control 1 Intervention

Wellness Ambassadors will undergo training to recruit and deliver a lifestyle intervention to members of their social networks. HCL in the delayed intervention group will deliver the intervention after 24 week data collection visits are complete.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A study involving 954 participants showed that a telephonic wellness coaching program led to a significant reduction in BMI, with a clinically meaningful decrease of over one unit after 12 months of coaching (P < 0.01).

In contrast, a matched control group of 19,080 individuals did not experience significant changes in BMI during the same period, highlighting the effectiveness of the wellness coaching intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of telephonic wellness coaching on weight loss: A "Natural Experiments for Translation in Diabetes (NEXT-D)" study. Schmittdiel, JA., Adams, SR., Goler, N., et al.[2019]

A qualitative study involving 10 adults with severe obesity revealed four key themes essential for maintaining weight loss over the long term: owning the decision, creating self-reinforcement, sustaining a lifestyle-forming identity, and selecting appropriate support.

The study suggests that successful weight loss maintenance is more about the intentional mindset behind behaviors rather than just the behaviors themselves, highlighting the importance of personal commitment and support in achieving lasting results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experientially Derived Model of Flexible and Intentional Actions for Weight Loss Maintenance After Severe Obesity. Natvik, E., Råheim, M., Andersen, JR., et al.[2023]

A community-based weight-loss treatment program involving 90 participants led to significant weight loss and sustained health improvements, including reductions in waist circumference and cholesterol levels, over an 18-month period.

Participants maintained their weight loss without significant regain at follow-ups, demonstrating the effectiveness of the program in promoting long-term behavioral and psychological benefits for overweight and obese adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. Latner, JD., Ciao, AC., Wendicke, AU., et al.[2013]

A randomized controlled trial involving 340 participants showed that a digital lifestyle coaching program led to a significant weight loss of 4.5 kg over 12 months compared to only 1.5 kg in the usual care group, indicating the efficacy of digital coaching for obesity management.

Both groups experienced reductions in hemoglobin A1c levels, suggesting improvements in blood sugar control, but there was no significant difference between the groups, highlighting that while weight loss was greater in the intervention group, blood sugar improvements were similar for both.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial. Hesseldal, L., Christensen, JR., Olesen, TB., et al.[2022]

The home telehealth intervention, which included telephone counseling and video support, did not significantly impact weight maintenance among 88 obese or overweight African-American women after a weight loss program, with both groups showing minimal weight change.

Low usage of the digital video recorders (DVRs) suggests that the video content may not have been effectively utilized, indicating a potential barrier to the success of the telehealth intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. Gerber, BS., Schiffer, L., Brown, AA., et al.[2022]

The telehealth-based lifestyle therapeutics (THBC) program was effective in promoting weight loss, with obese participants losing an average of 3.6% of their body weight compared to 2.5% for overweight participants, indicating a significant difference based on initial BMI category.

There were no differences in weight loss outcomes between men and women, and participants reported high satisfaction with the program, suggesting that THBC is a valuable tool for weight management in an employer population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. Johnson, KE., Alencar, MK., Miller, B., et al.[2021]

In a study of 225 participants in a telephonic health coaching program, those who engaged in at least 6 coaching sessions experienced a significant average weight loss of -3.5%, compared to a modest overall weight change of -2.1% for the group.

Despite the focus on weight management, the study found no significant changes in healthcare utilization or costs associated with program engagement, suggesting that while coaching can aid weight loss, it may not impact healthcare visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. Reid, N., Bennett, W., Coughlin, J., et al.[2020]

The Healthy Weight Coaching (HWC) program is a comprehensive 12-month internet-based intervention for obesity management that combines Acceptance and Commitment Therapy with personalized coaching, targeting diet, physical activity, psychological factors, and sleep.

With 1189 participants enrolled, the program emphasizes ongoing support through weekly weight logs and 26 scheduled online discussions with coaches, aiming to provide effective long-term weight management solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. Suojanen, LU., Ahola, AJ., Kupila, S., et al.[2022]

A qualitative study involving 20 African American church members identified key components for a faith-based weight maintenance program, emphasizing the importance of accountability, support, and faith in achieving healthy lifestyle changes.

Integrating faith themes, such as scripture and prayer, into weight maintenance programs may enhance their effectiveness in promoting long-term health behavior changes among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing culturally congruent weight maintenance programs for African American church members. Seale, JP., Fifield, J., Davis-Smith, YM., et al.[2022]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

Community-based weight control programs can effectively reach and treat large numbers of obese individuals who might not seek professional help, achieving modest weight loss at lower costs compared to clinical interventions.

While these programs have not yet succeeded in reducing overall obesity rates in the general population, they show promise and warrant further research, particularly in recruitment strategies and preventing weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minnesota studies on community-based approaches to weight loss and control. Jeffery, RW.[2019]

Community-based interventions that are grounded in theory and shaped by input from community members can lead to significant and lasting changes in addressing issues like obesity.

To effectively tackle obesity through community-based research, it is essential to train future leaders in these methods, secure funding for thorough trials, and gain scientific support for this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community interventions: a brief overview and their application to the obesity epidemic. Economos, CD., Irish-Hauser, S.[2017]

In a 12-week study involving 45 university students with obesity, the LEARN Program led to a greater average weight loss of 7.76 lbs compared to 2.5 lbs in the MI-via-CALC group, indicating that structured lifestyle education may be more effective for weight loss.

Participants in the MI-via-CALC group reported a greater reduction in caloric intake, suggesting that while it may not lead to as much weight loss, it effectively promotes self-awareness and personal responsibility in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CHANGE program: comparing an interactive vs. prescriptive approach to self-management among university students with obesity. Pearson, ES., Irwin, JD., Morrow, D., et al.[2013]

References

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

The impact of telephonic wellness coaching on weight loss: A "Natural Experiments for Translation in Diabetes (NEXT-D)" study. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

An Experientially Derived Model of Flexible and Intentional Actions for Weight Loss Maintenance After Severe Obesity. [2023]

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

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]

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

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. [2022]

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

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. [2021]

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

Evaluating an insurer-based health coaching program: Impact of program engagement on healthcare utilization and weight loss. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of a web-based real-life weight management program: Study design, methods, and participants' baseline characteristics. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Developing culturally congruent weight maintenance programs for African American church members. [2022]

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

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

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

Minnesota studies on community-based approaches to weight loss and control. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Community interventions: a brief overview and their application to the obesity epidemic. [2017]

13. Canada pubmed.ncbi.nlm.nih.gov

The CHANGE program: comparing an interactive vs. prescriptive approach to self-management among university students with obesity. [2013]