Activity Monitoring for Obesity

(ALMS Trial)

Overseen By Alice Staaby

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Regular exercise, Weight loss program, Pregnancy, Cognitive disorder, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical activity affects the quality of life and mental well-being of adults with severe obesity (BMI over 40). Participants will either track their activity using a wearable monitor or do the same with added weekly phone or Zoom check-ins (supportive communication sessions). The trial examines whether simply monitoring activity can boost physical activity levels over six weeks. Ideal participants are adults who sit or lie down for 9+ hours a day and aren’t currently engaged in any regular exercise or weight loss programs. As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle changes that could enhance well-being.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that activity monitoring is safe for adults with severe obesity?

Research has shown that using phone and Zoom calls to monitor activity is generally safe. One study found that phone calls in weight loss programs helped participants lose weight over six months without major safety issues. Another study examined digital methods, such as phone calls, to support adherence to health plans. It found these calls effective and reported no serious side effects.

These findings suggest that using phone or Zoom calls to track activity levels is safe and well-tolerated for most people. No major negative effects have been reported, making this method a promising option for those interested in a study on physical activity and obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support people dealing with obesity. Unlike standard options that often focus on diet and medication, this approach uses a combination of technology and personal support. Participants wear an ActiGraph activity monitor, which offers precise tracking of physical activity. Additionally, the trial includes weekly phone or Zoom calls with research staff, providing personalized feedback and motivation. This dual approach of technology and human interaction aims to offer a more comprehensive and engaging way to promote healthy activity levels.

What evidence suggests that activity monitoring is effective for improving physical activity in adults with severe obesity?

Research has shown that phone calls can aid in weight management. One study found that people lost about the same amount of weight through phone calls as with in-person clinic visits, and this weight loss exceeded some health guidelines. Another study demonstrated significant weight loss over six months when phone calls were included in the weight loss plan. In this trial, participants in the "Additional Follow-up" arm will receive regular phone or Zoom check-ins, potentially helping those with severe obesity improve physical activity and manage weight. ^{5 6 7 8 9}

Who Is on the Research Team?

Charles Emery, PhD

Principal Investigator

Cardiopulmonary Behavioral Medicine at OSU

Are You a Good Fit for This Trial?

This study is for adults with severe obesity (BMI over 40) who sit or lie down for most of the day (9+ hours). It's not suitable for those who can't stand without help, are currently pregnant or gave birth recently, have low education levels, suffer from depression, weigh over 400 lbs, have cognitive disorders like dementia, visual impairments that affect reading ability, or are already exercising regularly.

Inclusion Criteria

Your body mass index (BMI) is very high, which means you are severely overweight.

You spend more than 9 hours a day sitting or lying down.

Exclusion Criteria

Cannot stand up without assistance

Currently pregnant

Planning to get pregnant in the next 2 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Activity Monitoring

Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period

6 weeks

Weekly phone/zoom calls for in-depth monitoring

Follow-up

Participants are monitored for changes in physical activity, quality of life, and psychological functioning

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Phone/zoom calls

Trial Overview The trial aims to see how tracking physical activity affects quality of life and mental health in severely obese individuals. Participants will be monitored through phone or Zoom calls over a six-week period to assess changes in their activity levels.

How Is the Trial Designed?

Group I: Additional Follow-up Experimental Treatment 1 Intervention

In addition to receiving an ActiGraph activity monitor, participants will complete weekly phone/zoom calls with research staff for a more in-depth monitoring of their activity level.

Group II: Activity Level Monitoring Active Control 1 Intervention

Participants receive an ActiGraph activity monitor to track their activity level over a 6-week period.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4889333/

Distance learning strategies for weight management ... Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity will be assessed on the same schedule. In addition, a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3408567/

Weight management by phone conference call Thus, the conference call approach ultimately provided weight loss that was similar to that achieved in a FTF clinic and exceeded NHLBI clinical guidelines.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05180448

Sharing Digital Self-Monitoring Data With Others to ... The proposed study will enroll adults ("index participants") (N = 320) with overweight/obesity in a 24-month LM program and instruct them to use digital tools ...

4. nature.com nature.com/articles/s41366-025-01869-4

An extension study during the COVID-19 pandemic There is a great need for determining the effectiveness of telephone-based early obesity interventions targeting preschool-aged children.

5. endocrinologyadvisor.com endocrinologyadvisor.com/news/weight-loss-intervention-via-phone-calls-yields-6-month-weight-loss/

Weight Loss Intervention Via Phone Calls Yields 6-Month ... Weight loss intervention via phone calls was associated with significant 6-month weight loss among rural residents with obesity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9043385/

Impact of digital monitoring on compliance and outcome ... Conventional method included monitoring patients' adherence to diet and change in weight during in-person clinic visits or monthly phone calls from staff.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617195/

A Scientific Overview of Smartphone Applications and ... Some studies compare in-person contact (e.g., phone calls, group sessions) against technology (app), combine both, or examine different modes of ...

8. cdc.gov cdc.gov/pcd/issues/2018/18_0206.htm

Effect of Media Use on Adolescent Body Weight Adolescents who used electronic media 6 or more hours at night had higher odds of unhealthy eating behavior and inadequate sleep hours than those with 2 hours' ...

9. mdpi.com mdpi.com/1424-8220/22/3/1213

Telehealth Secure Solution to Provide Childhood Obesity ... We propose a secure remote monitoring and supervision scheme of physical activity and sleep hours for the children based on telehealth, multi-user networks.