Food Cravings Strategies During Dietary Weight Loss

NCT ID: NCT06280339

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2024-08-01

Brief Summary

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The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.

The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings.

Detailed Description

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Obesity is a major contributor to developing chronic diseases such as hypertension, heart disease, stroke, and diabetes, and 41.9% of adults were obese in 2020 in the United States. Although weight loss can reduce or remit these comorbidities , it is challenging for most individuals with obesity to achieve clinically significant weight loss and sustain healthy weight through dietary/lifestyle modifications. Achieving sustainable weight loss must be accompanied by dietary/lifestyle modifications that can be sustained comfortably for a lifetime. Currently, there is no dietary weight loss program that can reliably induce sustainable weight loss.

To address this deficiency, our lab has been developing a novel dietary weight loss program that can achieve a lifetime healthy weight. In our three weight loss trials, we observed that the reduction of food cravings is associated with successful weight loss and subsequent weight maintenance. Food cravings have been suggested to predict food intake and weight gain, lack of success in weight loss, and early drop-out from weight management programs, supporting our observation. Food cravings are defined as strong or intense desires for a particular type of food and have been reported to occur in approximately 58% of adults. Individuals with overweight or obesity report more frequent and intense cravings for energy-dense food, such as high-fat and sweet foods, relative to normal-weight people.

Specific food craving coping strategies are developed to reduce the frequency and intensity of cravings to minimize the risk of excessive food intake. These strategies involve cognitive-behavioral principles, including controlled-based strategies such as avoidance, resistance, and inclusion. The avoidance strategy uses behavior-oriented techniques to modify the immediate environment, teaching individuals to encourage healthy eating and avoid unhealthy eating by controlling the stimuli that trigger their behaviors. The resistance strategies focus on cognitive regulation and enhancing self-regulatory control, which teaches individuals how to cognitively restructure urges related to craved food and mentally distract themselves from cravings. The inclusion strategies focus on self-regulation and planning and aim to satisfy food cravings by strategically incorporating craved foods into balanced meals.

Despite the existence of coping strategies, very few studies evaluate the efficacy of these strategies during weight loss trials. Thus, we evaluated the relationship between weight loss outcomes and the degree of cravings using intra-cohort analysis in our two weight loss trials. Our preliminary findings suggested that effective management of food cravings appears to be a key to successful weight loss and weight maintenance. Study 1 found that better control over food cravings during weight loss and maintenance was associated with long-term success in weight loss outcomes. Study 2 demonstrated that participants who achieved clinically significant or greater weight loss (5% weight loss) had significantly lower food cravings.

Building on the findings from our preliminary studies, a specific aim of this research proposal is to determine the efficacy of craving coping strategies (and a combination of strategies) on weight loss outcomes by conducting a randomized controlled trial.

Conditions

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Obesity Food Cravings Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avoidance group

Avoidance Strategy: This strategy focuses on teaching individuals how to modify their immediate environments to make it easier to control food cravings. Examples include redesigning your home to remove tempting foods or limiting access to craved foods. It also covers tips on making grocery lists and communicating health goals within your social circle. Additionally, it includes a toolkit for situations where controlling the immediate environment may be challenging, such as at parties or social gatherings Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings.

Group Type EXPERIMENTAL

Test two food cravings strategies during dietary weight loss

Intervention Type BEHAVIORAL

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Dietary weight loss program +Food cravings strategies

Intervention Type BEHAVIORAL

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Inclusion group

Inclusion Strategy: This strategy teaches individuals how to modify their eating habits by paying attention to the portion size of craved foods and incorporating them into well-balanced meals, avoiding eating between meals. It also includes a toolkit for situations where individuals may struggle to include craved foods in their balanced meals.

Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings.

Group Type EXPERIMENTAL

Test two food cravings strategies during dietary weight loss

Intervention Type BEHAVIORAL

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Dietary weight loss program +Food cravings strategies

Intervention Type BEHAVIORAL

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Interventions

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Test two food cravings strategies during dietary weight loss

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Intervention Type BEHAVIORAL

Dietary weight loss program +Food cravings strategies

The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adult between the ages of 18 and 75
2. BMI of at least 28 and above

4- Have access to the internet 3- Report experiencing at least a moderate amount of food cravings, and they consume the craved food at least a few times per week.

Exclusion Criteria

1. Participation in a formal weight management program within the preceding three months.
2. Usage of medications impacting weight.
3. Being pregnant or breastfeeding.
4. Having a history of bariatric surgeries.
5. Diagnosed with DM type 1 or/and Use insulin injection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bevier HAll UIUC

Urbana, Illinois, United States

Site Status RECRUITING

Bevier HAll UIUC

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manabu Nakamura, PhD

Role: CONTACT

217-333-1267

Facility Contacts

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Nouf Alfouzan

Role: primary

217-898-5480

Nouf Alfouzan

Role: primary

217-898-5480

References

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Other Identifiers

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IRB23-0190

Identifier Type: -

Identifier Source: org_study_id

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