Clinical trial NCT06280339: Food Cravings Strategies During Dietary Weight Loss
Official title: Comparison of Coping Strategies to Reduce Food Cravings During Dietary Weight Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Food Cravings
Weight Loss
Keywords: Food cravings
Strategies
Weight loss
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline (0 month) to 3 month
measure: Food Craving Strategies Compliance
timeFrame: Change from baseline 0 week to 12 week runs-bi-weekly
measure: Food Cravings
timeFrame: Change from baseline 0 week to 6 week and week 12
measure: Food Cravings
timeFrame: Change from baseline 0 week to 6 week and week 12
Secondary outcomes:
measure: Dietary intake
timeFrame: Baseline. month 1, month 3
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Bevier HAll UIUC
state: Illinois
city: Urbana
country: United States
facility: Bevier HAll UIUC
state: Illinois
Study officials:
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